Supportive Clinic for Patients Living With Advanced and Metastatic Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with advanced or metastatic cancer
are at least 18 years of age
physically able to attend the supportive clinic.
Disqualifiers
Participants will be excluded from the study if they are non-Cantonese-, non-Mandarin-, or non-English-speakers.
Trial design
Design model
Parallel
Treatments tested in this trial
Supportive clinic
BehavioralDuring 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.
Control: Self-management
BehavioralEach 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Supportive clinicExperimental treatment 1 intervention
Group B: Control: Self-managementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of subject recruitment
number of participants consent and being randomized/number of eligible patients x 100
Time frame
baseline2
Rate of subject retention
number of participants who complete follow-up assessments at 6 and 9 months post-baseline/number of participants enrolled x 100
Time frame
baseline, 6-months and 9- months post-baseline3
Adherence rate to intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Time frame
immediate post-intervention4
Rate of missing data
number of participants with completed datasets for outcome measures/number of participant enrolled x 100
Time frame
baseline, 6-months and 9- months post-baselineSecondary outcomes
1
Change of self-efficacy
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.
Time frame
baseline, 6-months and 9- months post-baseline2
Change of supportive care needs
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.
Time frame
baseline, 6-months and 9- months post-baselineSponsors and contacts
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Source ClinicalTrials.gov