Survivorship Intervention for Patients Living With Advanced and Metastatic Cancers: a Randomized Controlled Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- The University of Hong Kong
- Enrollment
- 68
- Locations
- 5
- Primary Endpoint
- Adherence rate to intervention
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Adherence rate to intervention
Time Frame: immediate post-intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Rate of missing data
Time Frame: baseline, 6-months and 9- months post-baseline
number of participants with completed datasets for outcome measures/number of participant enrolled x 100
Rate of subject recruitment
Time Frame: baseline
number of participants consent and being randomized/number of eligible patients x 100
Rate of subject retention
Time Frame: 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
Change of symptom distress
Time Frame: 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
Time Frame: 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 Outcomes
- Change of self-efficacy(baseline, 6-months and 9- months post-baseline)
- Change of supportive care needs(baseline, 6-months and 9- months post-baseline)