Cancer, Physical Symptom Distress
Conditions
Keywords
Physical symptom distress, self-efficacy in managing cancer, health-related quality of life, survivorship intervention, advanced cancer, randomised controlled trial, psychooncology
Brief summary
To conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the survivorship care intervention on patient-reported outcomes, defined as symptom distress and health-related quality of life.
Detailed description
The primary aim of this study is to examine the feasibility and acceptability of conducting a randomized controlled trial (RCT) that evaluates a community-based survivorship care intervention to reduce symptom distress and improve health-related quality of life and self-management efficacy among patients with advanced or metastatic cancer. No hypothesis was proposed for this feasibility trial as the current Consolidation Standards of Reporting Trials (CONSORT) guidelines for reporting feasibility trials do not recommend hypothesis testing of clinical outcomes. The rationale is that pilot trials are often underpowered to detect differences, and this should be the aim of the main trial.
Interventions
BEHAVIORALSupportive clinic
During the visit, each patient will receive a personalized feedback summary, including an assessment and recommendation on managing physical and psychological symptoms, an evaluation and recommendation on dietary advice, an assessment and recommendation on physical activity, and advice on managing potential psychosocial issues by the multidisciplinary team.
BEHAVIORALControl: Self-management
Each pamphlet given to the patients addresses one of the 7 most commonly-reported symptoms (sleep difficulties, fatigue, neuropathy, pain, anxiety, depression, and fear of cancer progression) observed in Hong Kong patients with advanced or metastatic cancer, plus two on lifestyle recommendations (physical activity and eating well). All pamphlets are developed based on the self-management framework.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to the intervention or the control arm. The participants are masked in terms of not knowing that the intervention are hypothesized to yield larger effects than the others (i.e. controls).
Intervention model description
This is a 2-arm feasibility trial study with an intervention group and a control group. Computer-generated block randomization sequences will be generated by a statistician who is blinded to the identity of participants prior to the start of the trial. A block randomisation structure with randomly permuted block sizes of 2 and 4 will be used to reduce selection bias and ensure close balance of the numbers in each arm. The serially labelled opaque sealed envelope method will be used for randomisation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with advanced or metastatic cancer * are at least 18 years of age * physically able to attend the supportive clinic.
Exclusion criteria
* Participants will be excluded from the study if they are non-Cantonese-, non-Mandarin-, or non-English-speakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of subject recruitment | baseline | number of participants consent and being randomized/number of eligible patients x 100 |
| Rate of subject retention | baseline, 6-months and 9- months post-baseline | number of participants who complete follow-up assessments at 6 and 9 months post-baseline/number of participants enrolled x 100 |
| Adherence rate to intervention | immediate post-intervention | number of participants who complete the intervention/number of being allocated to attend the intervention x 100 |
| Rate of missing data | baseline, 6-months and 9- months post-baseline | number of participants with completed datasets for outcome measures/number of participant enrolled x 100 |
| Change of symptom distress | baseline, 6-months and 9- months post-baseline | The 10-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 10 symptoms commonly observed in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep. A numerical rating scale 0 (no symptom at all) to 10 (the worst possible symptom) is used to measure distress associated with each symptom. ESAS has been widely adopted worldwide for standardized symptom screening in routine cancer care including palliative care, The total scores ranges from 0 to 100, with a higher score indicating greater total symptom distress. The minimal clinically important difference for improvement of the ESAS total symptom scores is 5.7 . |
| change of health-related quality of life | baseline, 6-months and 9- months post-baseline | The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) will assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty. All of the scales range in score from 0 to 100.The 10-point EORTC-QLQ-C30 scores changes are considered to be clinically important. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of self-efficacy | baseline, 6-months and 9- months post-baseline | Self-efficacy assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS). This is a 6-item scale assessing patients' confidence to perform six self-management behaviours. Each item is rated on a 10-point Likert scale, with a total score ranging from 6 to 60. A high score indicates high self-efficacy. It has been used with cancer patients. |
| Change of supportive care needs | baseline, 6-months and 9- months post-baseline | The Chines version of the 44-item Supportive Care Needs Survey for Partners and Caregivers (SCNS-P\&C) will be used to assess caregiver support care needs. The SCNS-P\&C assesses four domains of needs: Health care service needs, psychological and emotional needs, work and social needs, and information needs. Each item is rated on a 4-item scale (1= no need, 2 = low need, 3 = moderate need, and 4 = high need). A high score indicates greater unmet supportive care needs. |
Countries
Hong Kong
Contacts
CONTACTWendy Lam, Phd
CONTACTDanielle Ng, Phd
PRINCIPAL_INVESTIGATORWendy Lam, Phd
School of Public Health, The University of Hong Kong
Outcome results
None listed