Condition category
Cancer
Date applied
16/12/2016
Date assigned
05/01/2017
Last edited
18/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer is often associated with severe physical and psychological suffering, especially during the terminal phase of the disease. Further, with the deterioration of the cancer patient, family members who provide care to these patients may suffer from increased anxiety, leading to a decline in their ability to provide effective care. It is therefore important to develop strategies to relieve the suffering of patients and caregivers alike. Previous studies have suggested that massage relieves many symptoms experienced by cancer patients, including pain, fatigue and anxiety. Further, massage was also shown to promote a sense of connectedness and reduce unnecessary emotional distancing between family caregivers and patients. All these suggest that massage may improve the effectiveness of care provision for cancer patients by family caregivers. A massage program would therefore be appropriate as one strategy of palliative care for patients with terminal cancer. This study aims to investigate whether a caregiver-delivered massage program would be feasible and acceptable to patients with terminal cancer in a home care setting. It also aims to find out whether this program reduces the level of distress and enhances the quality of life of both caregivers and patients.

Who can participate?
Patients with terminal cancer who are taken care of by family caregivers in their own homes. Both the patients and the caregivers must be above the age of 18

What does the study involve?
Participants are randomly allocated into two groups (Group A and Group B). In Group A, the caregivers receive training from an experienced palliative care nurse on gentle massage techniques at the caregivers’ homes, using almond oil as the massage oil. During the training, detailed instructions are provided, and a video clip is shown to the caregivers for them to gain mastery of the massage techniques. The caregivers then provide sessions of gentle massage to the upper limbs of their cancer patients three times a week for 15-20 minutes per session. Both before and after the massage program, the cancer patients are required to complete a questionnaire and undertake certain tests in order to assess the severity of their symptoms, quality of life, level of distress and sleep quality. Likewise, the caregivers need to complete the questionnaire and tests for the assessment of their quality of life, level of distress, sleep quality, as well as their perceived preparedness and competence to provide care to the cancer patients. For Group B, for the first four weeks after joining the study, the family caregivers deliver their normal care to the cancer patients. They are required to complete the questionnaire and undertake the tests as described above both one and four weeks after joining the study. Participants in Group B then receive the massage program as described above after Group A have completed the study.

What are the possible benefits and risks of participating?
The massage is expected to relieve the symptoms experienced by cancer patients, reducing their stress and anxiety levels and improving their quality of life. In addition, this massage program may also help relieve the level of distress experienced by family caregivers when providing care to the cancer patients. This in turn may enhance the preparedness and competence of these family caregivers in the provision of care, resulting in better quality of care received by the cancer patients. Side effects are not expected to occur.

Where is the study run from?
Caritas Medical Centre (Hong Kong)

When is the study starting and how long is it expected to run for?
November 2016 to October 2017

Who is funding the study?
Chinese University of Hong Kong (Hong Kong)

Who is the main contact?
Prof. Winnie K.W. So

Trial website

Contact information

Type

Scientific

Primary contact

Prof Winnie So

ORCID ID

http://orcid.org/0000-0001-9243-2924

Contact details

7/F
Esther Lee Building
The Nethersole School of Nursing
Chinese University of Hong Kong
Shatin
The New Territories
Hong Kong
N/A
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 2

Study information

Scientific title

A feasibility study of caregiver-delivered massage program for cancer palliative care patients

Acronym

Study hypothesis

1. The caregiver-delivered massage program is feasible and acceptable to Chinese patients with terminal cancer
2. This program helps reduce the level of distress and symptom burden, while improving sleep quality and quality of life of these patients
3. The program increases the perceived preparedness and competence of the family caregivers of these cancer patients in care delivery, improves their sleep quality and quality of life, and reduces their distress level

Ethics approval

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee, 14/09/2016, ref: 2016.453

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Terminal cancer

Intervention

Before the intervention, dyads (pairs of caregivers and cancer patients) will be randomized into intervention or wait-list control group. Each group will have 20 dyads. Double-blind randomization will be carried out for the purpose of subject allocation. A computer-generated randomization scheme with block sizes of 4 will be carried out by a research staff independent of the research team. Group allocation will be concealed by using consecutively numbered opaque sealed envelopes which will be opened after consents are obtained from the dyads.

The intervention involved in this study is a caregiver-delivered massage program, which is going to last for three weeks. During the intervention, family caregivers will be asked to follow the intervention protocol and provide the gentle massage to upper extremities of their corresponding patients 3 times per week for approximately 15-20 minutes per session.

Participants allocated to the wait-list control group will only receive the massage intervention after the participants in the intervention group have completed the massage intervention.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Distress levels of patients and family caregivers will be measured using the distress thermometer, a visual analogue scale used to evaluate psychological distress at baseline and 3 weeks
2. Symptom burden will be measured using the Edmonton Symptom Assessment System at baseline and 3 weeks
3. Sleep quality of both patients and caregivers will be evaluated by the use of a wrist-worn sleep tracking device which will monitor the various sleep parameters of the participants, including total sleep time, sleep latency, sleep efficiency, immobility time, mean activity score, and number of awakening at baseline and 3 weeks
4. Quality of life of patients will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL). Quality of life of family caregivers will be measured using the Short Form 12 Health Survey Questionnaire (SF12v2) at baseline and 3 weeks
5. Perceived preparedness of family caregivers will be measured using the Preparedness for caregiving scale, while their perceived competence will be measured using the Caregiving Competence Scale at baseline and 3 weeks

Secondary outcome measures

1. Recruitment rate
2. Retention rate
3. Participant compliance to the intervention
4. Participant satisfaction

Overall trial start date

01/11/2016

Overall trial end date

31/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Aged 18 or above
2. Diagnosed with cancer
3. Able to communicate in Chinese
4. Staying at home
5. Willing to comply with the proposed intervention

Family caregivers:
1. Aged 18 or above
2. Able to communicate in Chinese
3. Willing to comply with the proposed intervention

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

40 pairs of patients and their caregivers (dyads)

Participant exclusion criteria

1. Patients with deep vein thrombosis, devices and obvious skin problem/fracture/metastasis of the upper limb(s)
2. Patients and caregivers with any cognitive impairment that interferes with the completion of the study
3. Allergic to almond oil

Recruitment start date

01/02/2016

Recruitment end date

30/04/2017

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Caritas Medical Centre
Wai Yee Block 111 Wing Hong St Sham Shui Po
Hong Kong
-
China

Sponsor information

Organisation

Chinese University of Hong Kong

Sponsor details

The Nethersole School of Nursing
Shatin
The New Territories
Hong Kong
-
Hong Kong

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Chinese University of Hong Kong

Alternative name(s)

CUHK

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Hong Kong

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Winnie K.W. So

Intention to publish date

31/10/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/07/2017: Internal edit.