Depression, Longevity of Life, Pain

This research proposal is for cancer patients’ depression, longevity of life, pain, and physical measurable effect the integrative CREATE Program may have for patients with metastatic disease who are receiving or have been recommended orthodox anti-cancer treatment.

1.  Title

People with gastro-intestinal cancer: a pilot study of the effects of the CREATE programme on health and quality of life.

2.  Benefits of the proposed investigations

Improving the experience of care for those affected by cancer is a clear commitment for governments’ cancer plans.  This study investigates how CREATE might contribute to this commitment.  Case study evidence exists that demonstrates positive effects from and complementary and alternative therapies (CAM) as a part of supportive and palliative care.  However, availability within a structured Program that is tailor-made for the individual is limited. This study aims to fill part of this research gap.

CREATE is adjusted for those with less advanced disease. For those receiving palliative care, CREATE offers a treatment programme integrated with orthodox medicine that may extend life and improve quality of life. CREATE includes self-healing elements to help patients focus on their illness in a positive way and cope better with the trauma that the illness has brought into their lives.   

Expected cost benefits include reduced medication, less visits to consultants/specialists, and referrals to other specialists.  Governmental and medical resources may then be targeted more effectively. We also expect a measurable reduction in tumour size in many cases.

The analysis of questionnaires will help build a profile of those who best respond to CREATE therapies, and show how CREATE could improve patients’ quality of life. 

This research will also contribute towards an analysis of what CREATE and orthodox medicine can learn from each other in order to raise the standard of ‘best’ care for patients with cancer.

The rationale for focusing research on gastro-intestinal cancers is two-fold.  First, although it is the third-most common cancer, it is relatively under-researched.  Secondly, it appears there has been little examination of gastro-intestinal cancer in relation to therapies outside orthodox medical interventions. 

3.  Background to this CREATE research project proposal

There is a need for research into CREATE provided as a Program of interventions.  Although the literature contains a number of different studies of CAM relevant to CREATE, little is reported specifically for people with cancer who can attend a structured Program of therapies. 

CREATE offers many therapies. To take one as an example, ‘Bio-field Medicine’ has been documented in a study as an adjuvant to opoid therapy in the management of pain (Olson & Hanson 1997) and there is an abundance of anecdotal records, including some emerging scientific evidence, that reiki is effective in decreasing physical problems and anxiety associated with illness (Bullock 1997), and can be used in the design of randomised placebo-controlled trials (Mansour et al 1999). In 1998, over 870 patients at Columbia/HCA Portsmouth Regional Hospital in New Hampshire, USA received a 15-minute pre-and post-surgery Reiki treatment.  As a result there was less use of pain medications, shorter lengths of stay and increased satisfaction (Aladydy et al 1999). There are also many studies of other therapies used within CREATE that show significant outcomes. 

The potential of CAM therapies to be used with conventional medicine is significant and is already used in cancer care hospitals and hospices in the UK such as Canterbury.  In order for CREATE to become a recognised treatment it needs to be properly documented within an approved medical setting; this is the aim of our cancer proposal.

Through experience with cancer patients, including with advanced tumour-based cancers, CREATE has assimilated diverse elements of a CAM approach into a highly integrated chronologically ordered system.  After working with clients with consistent and yet extensive success, CREATE has now earned properly supervised study and further investigation. 


4a1. Questionnaire

The questionnaire will be semi-structured and covers the perceptions of people with gastro-intestinal cancer about CREATE and CREATE treatment as well as their expectations and experiences of cancer care.  It will include socio-demographic characteristics, attitudes to conventional and alternative treatments (assessed using Likert scale responses), use of services, and QOL assessed using the EORTC QLQ-C30 (Aaronson et al 1993). 

For those in the Part 1 study only, questionnaire will be administered three times, once on intake into the study, and at three and twelve months later.   For those individuals in part 2, they will sub-divide into three groups, the criteria for which are discussed below in 4b.  The three groups are: those receiving the CREATE treatment, those who were not receiving the CREATE programme due to therapist capacity constraints at the time they first attended the clinic, and thirdly, those who are not receiving the CREATE treatment because they are not suitable.  This third group will receive the questionnaires at the same times as those who are in Part 1 only, i.e. at three and twelve months.  Those in the first two groups will have the questionnaire at intake, after two weeks, and then at three and twelve months.  At twelve months for those who have received the CREATE programme, the questionnaire will be administered to individuals, including a number of open questions to explore their experience of CREATE and other aspects of their treatment.  This would be recorded for analysis with the patient’s permission.

4a2. Health service recorded data

The research nurse from clinic records will collate data on tumour size and use of other health service referred services for each individual in both parts of the study.  Tumour size will be assessed utilising conventional UICC or RECIST criteria with predefined assessment points and measurement methodology and logging of concurrent medication.  There is no additional cost associated with this data as it is collected routinely in the clinic upon intake and throughout the time the patient is under the care of the clinic.

4b.  Stages of the study

Study participants will be recruited from volunteers. 

The research nurse will approach each such individual and, if they are aged 21 to 75, seek their consent to participate in both Parts of the study, patients may elect just to participate in Part 1 if they so wish.  Individuals aged 56 and over will be asked if they wish to participate in Part 1 only.

4b1. Recruitment into Part 1

The research nurse will assess whether or not the new patient has sufficient English skills to complete the questionnaire, with up to 90 patients within 9 months.     

Individuals participating in Part 1 only, will then be sent two successive questionnaires to fill in and return by post at 3 and 12 months.  Reply paid envelopes will be provided. The research nurse will identify any patients who have died, so that distress caused to family members by arrival of post addressed to the deceased will be avoided.

4b2. Recruitment into Part 2:

We will recruit up to 40 patients into Part 2.  As soon as 40 patients are being treated with the CREATE programme, recruitment into Part 2 will cease.

The research nurse will introduce the Part 2 study to all new patients aged 21 to 75.  For anyone who is interested, she will explain that there is the possibility of them receiving a CAM treatment programme that is available at CREATE’s Margate clinic, or in the patient’s home.  She would then explain that not all clients who wish to receive the treatment would be able to do so.  She will be able to give them brief information about the length and nature of the programme and will give them an information leaflet.  She will explain that if they are interested, a qualified CREATE tutor or therapist will telephone them within 24 hours to discuss details and answer any questions the patient may have.  For anyone not interested in Part 2, the research nurse will ascertain if they would be interested in participating in Part 1 of the study.

A medical doctor will assess whether each of the patients who have expressed interest in Part 2 meet the selection criteria or not following a first consultation with the patient.  The doctor will submit a checklist form along with the contact information to the senior CREATE therapist, who then makes two categories of calls.  For those who fail to meet the selection criteria, they will immediately be told that there are unfortunately no therapists available and they will be reminded of other services that may be accessed through referral from the clinic.  For those who do meet the criteria the senior therapist to explain the study will contact the patient.  The selection criteria are: English proficiency, aged between 21 and 75 years, with advanced or metastatic GI cancer and no co-morbidity.  Patients should have at least a predicted three-month survival.  This senior therapist would call the patients in the order in which they were seen at the clinic, and if suitable would be offered treatment provided there is a therapist available to start work with them immediately.  If they are not suitable or if there is no therapist available immediately, it will unfortunately have to explained to the patient that they cannot be accommodated on the CREATE programme.  They will be reminded of the other services available through referral from the clinic and that we would welcome their views through subsequent questionnaires.

For those consenting to participate, the following steps would occur.  All others would get a follow-up EORTC QL 30 questionnaire at 1 month and every three months thereafter, ending at 1 year, the same as the self-selected treatment group.

The therapist would then be assigned by the study co-ordinator and within two to three days would begin to provide the intensive programme (6-9 hours a day for 12 near-consecutive business days; possible 6-day week) for 12 days treatment in total.  At the end of the treatment programme, the questionnaire will be administered as planned and a clinical assessment undertaken.  The therapist would also schedule a single follow-up session 6 weeks after intensive programme ends.

The final questionnaire at twelve months will be administered by the research fellow (both aspects, the quality of life and the CREATE exploration), who will be able to introduce him or herself as independent of the health service and CREATE services that the patient has received.  This will be conducted at the person’s home or other agreed space as the client wishes and will include open-ended questions on both aspects of the investigation including the four points in the queries in the call for proposals.

For both Part 1 and Part 2 participants, the questionnaires will be self-completed and returned in a pre-paid envelope.  The exception to this is that the 40 CREATE participants will receive an administered questionnaire at the year-end.

4c.  Study timetable

Time                                  Activity

December to January          Prepare and submit ethics application, recruit research fellow and nurse

March – April                     Finalise design of questionnaire, gain ethical approval

May                                   Start recruiting into study

January                               Last month for recruiting into Part 1 (recruitment to Part 2 will close when 40 patients are treated; we anticipate this will be before March.)

February                             Analysis starts

September                          Start report writing

January                               Final month of data collection

February                             Complete analysis and report writing

4d.  Analysis

4d1.  Part 1

Multiple logistic regression analysis will be used to explore how perceptions of CREATE treatments are influenced by socio-demographic characteristics, nature and stage of disease, services used (both orthodox and CAM), and professionals’ views (insofar as individuals are aware of these).   We will compare QOL outcomes over a one-year period among respondents, who, based on their answers, will be assigned an attitude band.  We will also conduct analysis on QOL and CREATE uptake or lack of CREATE uptake; the first group would be further divided into those who independently access a CAM modality and those who participate in Part 2 (see below).

4d2.  Part 2  

The analysis in Part 2 of the study will explore the CREATE programme’s efficacy.  This will be explored in terms of increased longevity, any tumour size reduction, and improvements in QOL.  Those who are assessed as suitable for Part 2 but could not participate due to therapist capacity limitations will form a comparison group for those who entered the CREATE treatment programme.  It is likely, however, that as we were not able to offer treatment to this group, they will decline to fill in further questionnaires.  However, we will still be able to compare them in terms of survival.

4e.  Ethical considerations

In offering the CREATE treatment, we need to be very sensitive to not raise people’s hopes that the programme might increase longevity or reduce tumour size.  This will be accomplished by not giving guarantees and delimiting the potential physical benefits discussed to those that are already supported by research data such as relief of pain or negative effects of chemotherapy (e.g. Olson & Hanson 1997, Astin at al 2000).

When we are in the position of necessitating rejection of an interested patient for participation in Part 2, we must always utilise the capacity constraints of the programme as the reason of the rejection in order to prevent any despair, depression or further hopelessness.  For this reason, when introducing Part 2, the research nurse will be explicit in notifying the patients that capacity is limited and not everyone who wishes to receive the CREATE treatment will be able to do so. 

Should the patient, after speaking with the senior therapist, wish to further participate, the study co-ordinator will only then be contacted by the senior therapist to match therapist to patient.  The waiting patient would be contacted by the senior therapist within an hour of the conversation with the senior therapist and would then be provided with either therapist information or a carefully presented rejection.  So, n order to mask the selection criteria, it would always be put on therapist availability.

The research nurse would also explain that therapist availability is subject to shifts.  Moreover, every patient considering entry to Part 2 is given an information leaflet and private time to consider whether or not they wish to receive the CREATE programme.

Participants in the study will be assured of the complete confidentiality of all the information they give and which will only be seen by the study team.  The team will maintain data using a unique participant identifier, which will only be linked to name when a questionnaire is sent out, administered or received.  Data presented in any report will be anonymised.   Data will be kept under lock and key and on password protected computers on the secure premises registered under the Data Act for the conduct of such studies as this.  They will also be assured that the final, administered questionnaire will be given by a third and neutral party with ties to neither the researching clinic nor to CREATE.

Addendum items:

  • Cost-saving measures incorporated into the study include the use of self-administered Likert scale questionnaires
  • And the use of CDs to record.
  • To ensure quality assurance and best practice that therapists can successfully offer the intensive CREATE programme satisfactorily, all therapists will receive full training and evaluation in order to qualify for the study.
  • Therapists who have passed the programme and take clients will have a debriefing session and counselling supervision with a senior and appropriately qualified supervisor. 
  • Those with most experience of the programme will serve as therapy consultants to further ensure best practice.  We will also provide supervised days of treatment.

5.      Project milestones

End December            First steering group meeting

End January                Submit ethics application

1 March                     Research nurse and Research fellow in post

End March                 Second steering group meeting

31 April                      Ethical approval obtained

1 May                        Study recruitment starts

                                  Research database set up

End July                     Third steering group meeting

End October               Fourth steering group meeting

End January                Last month for recruiting into study

                                  Fifth steering group meeting

1 February                  Analysis starts

End April                    Sixth steering group meeting

1 September               Start report writing

End October               Seventh steering group meeting

1 January                    Start drafting papers for publication

End January                Finish data collection

End February              Complete analysis and report writing

                                  Final steering group meeting

6.  Methods for disseminating and implementing research results

  • Publication in peer-reviewed journals
  • Conferences
  • Presentations
  • Websites
  • Extant charities
  • CREATE may promote further research.
  • Doctor-Healer Network: presentations at their meetings, article in their newsletter
  • CAM organisations
  • Mainstream CAM publications

Please CLICK HERE If you know someone who may help fund this research project