Tumour Reduction, Quality of Life

Funding of this research will investigate supportive therapy of CREATE in cancer patients for quality of life, depression, pain, and tumour reduction

1.1        Introduction

Cancer is the biggest challenge facing humanity in the present era and is poised to become the number one killer in the world with estimated 25 million people living with cancer worldwide (1).

In the UK one in four deaths are due to cancer making it the leading cause of mortality (2).

1.2        History

The Program Cancer Research and Evaluation using Active Therapeutic Evaluation (CREATE) was created in the late 1990s. Since then it has been used with cancer patients with good results.  This investigation will attempt to provide systematic case study reports of the effectiveness of CREATE. 

1.3        Palliative medicine

Most cancer patients are offered palliative care in advanced stages of malignancy and/or management of symptoms. Pain remains a big issue facing patients with advanced malignancy, and various data suggest prevalence rates of pain in 30-40 % of patients undergoing active therapy and 70-90 % of patients with advanced disease (3). 
The SUPPORT (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments) study in US indicated 50% of conscious patients dying in the hospital were reported by their surviving family members to have been in moderate to severe pain in the last week of life (4).

This study is just one of many that indicate a clear need for investigating better options for pain relief in palliative care.

1.4        Complementary and alternative medicine

Complementary and Alternative Medicine (CAM) represents an extension and expansion of supportive care, and as such is especially beneficial to patients undergoing palliative care.  Complementary modalities are available to patients at all stages of disease. 

According to The Oxford Textbook of Palliative Medicine, complementary therapies appear to be safe, non-toxic, and are non-invasive.  Complementary or supportive modalities can be soothing, comforting and can enhance quality of life.  Research has shown that these minimally invasive non-toxic therapies effectively reduce anxiety, depression, pain, dyspnoea, nausea and fatigue, which are common problems in palliative care patients (5).

1.5        Research studies

The growing reputation of the potential benefits of CAM is resulting in an increase in research into the different therapies comprising CAM (6)

As an example of evidenced CAM research, there is an emerging body of evidence for the beneficial effects of treatment methods of therapeutic touch, or gentle touch in the treatment of cancer patients.  Benefits consistently reported include control of pain, dyspnoea, and the relief of other distressing physical symptoms, to improvement in psychological symptoms like anxiety, insomnia, and depression.

Weze et al, collected data from 35 cancer patients who received healing by gentle touch. The study showed significant improvement in psychological and physical functioning with positive effects on quality of life.  The study found no adverse effects from the treatment (7).

Olson K et al conducted a phase II trial in which patients received either standard opioid management with rest (Arm A) or standard opioid management plus reiki (Arm B).  The result showed significant improvement in quality of life in the reiki Arm (8).

Giasson M et al confirmed that three non-contact therapeutic touch treatments increased the sensation of well being in persons with terminal cancer (9).

The utilisation of psychological and psychiatric interventions in the treatment of cancer patients with pain and psychological distress has now also become an integral part of such a comprehensive approach (10).

In patient population with cancer pain, negative thoughts about pain have shown to be significantly related to pain intensity, degree of psychological distress, and level of interference in functional activities (11,12).

Spigel and Bloom demonstrated in a controlled randomised prospective study the effect of supportive group therapy for metastatic breast cancer patients in general, and in particular the effect of hypnotic pain control exercises. The treatment arm of patients experienced significantly less pain than the control patients (13).

CREATE Therapies

We plan to offer the integration of various therapeutic modalities like counselling and other cognitive behavioural therapies of meditation, visualisation, and guided imagery. These modalities have illustrated positive effects in many studies, both alone and in combination with other conventional therapies.

The study would recruit, research and evaluate at least one potentially terminal cancer patient per month for six months during the six-month research period.  For the purposes of this particular study, each patient needs one-week set-up, two weeks for treatment and one week for evaluation.  If time permits, we will accept additional patients into the study. Patients will be accepted into the study if they have shown no progress on conventional oncology treatments and are receiving palliative care. This would remove any confounding factor due to active oncology treatment.

The schedule for therapy is about six hours per day of therapy over two weeks.

Any possible side effects will be monitored.  Pre- and post-treatment parameters will be measured.  Follow-up will be every three weeks, with a general physical examination, quality of life questionnaire, visual analogue scales for pain, and Becks depression inventory for psychological state. 

Interim analyses of collected data as shown in ‘Trial outline’ will be done after three and six months.

Conclusion will be drawn after follow-up at twelve months.  Alternatively, death will be an end-point. 

2.         Trial outline

This is a pilot study designed to assess the efficacy of CREATE in potential terminal cancer patients.  If conclusions are drawn from the study that outcomes and results are positive, we intend to formulate a larger scale study both within UK and abroad.  The model is:                                                 

2.1        Recruitment

2.1.a     Minimum of six patients with a diagnosis of advanced cancer

2.1.b     Patients will be adequately informed and consented

2.1.c     Treating oncologist and general practitioner will be informed

2.2        Pre-treatment evaluation

2.2.a     General physical examination, including blood samples if not taken recently

2.2.b     ECOG performance status

2.2.c     Quality-of-life questionnaire EORTC QLQ-C30 

2.2.d    Becks depression inventory for psychological assessment

2.2.e     Visual analogue score for pain

2.2.f     Height (in metres), weight (in kg) and body surface area

2.3        CREATE Program

2.3.a     Two weeks’ duration

2.3.b     Six hours (+/-) daily

2.3.c     Time spent to be determined by the patient’s individual needs

2.4        Follow up every three weeks

2.4.a     General physical examination

2.4.b     ECOG performance status

2.4.c     Quality of life questionnaire

2.4.d     Visual analogue scale for pain

2.4.e    Becks depression inventory

2.4.f     Height (in metres), weight (in kg) and body surface area

2.5        Conclusions

2.5.a     Conclusions will be drawn after follow-ups at 3, 6, and 12 months.

2.5.b     Alternatively, death will be an end point.

3.         Objectives

The primary objective of the study is to evaluate the effectiveness of CREATE in supporting potential terminal cancer patients. Objectives include:

3.1        Primary objectives

3.1.a     Quality of life scores

3.1.b     Pain scores

3.1.c     Psychological assessment as measured by Becks depression inventory

3.2        Secondary objectives

3.2.a     Overall survival

3.2.b     Monitoring of any side effects

4.         Eligibility criteria

4.1        Inclusion criteria

4.1.a     Histologically proven cancer

4.1.b     Further oncological intervention, chemotherapy/ radiotherapy/ hormonal or immunotherapy not planned or refused

4.1.c     Age: 21 – 75 years

4.1.d    Written informed consent must be obtained from the patient

4.1.e    ECOG Performance status 0,1,2,3 or 4

4.2        Exclusion criteria

4.2.a     Patients with a medical or psychiatric condition that impairs ability to give informed consent

4.2.b     Patients unable to complete the quality of life questionnaire

4.3        Treatment withdrawal criteria

            Patient decision to discontinue therapy

5.         Treatment regime

Patients will receive treatment in CREATE’s clinic, or at home or in hospital in conjunction with other standard or planned treatment.  The CREATE Program is designed to be flexible in the amount of time needed, dependent upon the needs of each patient.  It is anticipated that patients will need to allow for their treatment an average of six hours per day over a period of two weeks. 

History taking and psychological assessment will be a part of pre-treatment evaluation, and patients may withdraw consent at this stage.

6.         Follow-up & statistical analysis

All patients will be followed up in various ways to ensure adequate measures of outcomes.  These include:  

6.1        Every three weeks

6.1.a     General physical examination & ECOG performance status

6.1.b     Becks depression inventory for psychological assessment

6.1.c     Quality of life questionnaire

6.1 d    Visual analogue scales for pain

6.2       Preliminary statistical analysis

This would be done immediately after the patient’s treatment is completed

Follow-up survival data would be analysed after three months, six months and conclusion will be drawn after a follow up of 12 months

7.         References

1.         Parkin, D.M., Bray F.I., & Devesa S.S. (2001).  European Journal of Cancer, 37, 4-66. Cancer burden in the year 2000 – The Global Picture. 

2.         Office of National Statistics, DH2, No.27, The Stationary Office, London (2001).  Variation in selected causes of death by age in England and Wales in 2000.

3.         Greenwald H.P., Bonica J.J., (1987). Cancer 60, 2563-h9). The prevalence of pain in four cancers

4.         SUPPORT Principal Investigators. JAMA (1995); 274:1591. A controlled trial to improve care for the seriously ill hospitalized patients: the study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). 

5.         Doyle Derek et al, Oxford textbook of palliative medicine Third edition (2004)

Complementary Therapies in Palliative Medicine, 1087-1093,

6.         Final Report to the Department of Health and King’s Fund, University of Westminster.

Clinical Governance for CAM in Primary Care 2004

7.         Weze C., Leathard H.L., et al, Eur J Oncol Nurs. 2004 Mar., 8 (1): 40-9. Evaluation of healing by gentle touch in 35 clients with cancer. 

8.         Olson K., Hanson J., et al, Pain Symptom Manage.  2003 Nov; 26(5): 990-7. A phase II trial of reiki for the management of pain in advanced cancer patients. 

9.         Giasson M, Bouchard L., J Holist Nurs. (1998) Sep; 16(3): 383-98 Effect of Therapeutic touch on the well being of persons with terminal cancer.

10.        Doyle Derek et al, Oxford textbook of palliative medicine Third edition 2004(pages 424-438) Psychological and psychiatric interventions in pain control.

11.        Syrjala, K., & Chapko, M., (1995). Pain 61, 69-79. Evidence for a biopscyhosocial model of cancer treatment related pain. 

12.        Payne D. (1995) Unpublished dissertation, 1995 Cognition in cancer pain. 

13.        Spiegel D & Bloom JR (1983): Psychosomatic medicine 4,333-9. Group therapy and hypnosis reduce metastatic breast cancer pain.