NCT04159363 — A Psychosocial Intervention for Patients With Colorectal Cancer and Their Family Caregivers · CancerIndex
Clinical trial · Interventional
A Psychosocial Intervention for Patients With Colorectal Cancer and Their Family Caregivers
The Effectiveness of an Interactive Colorectal Cancer Self-Management Enhancement Smartphone-based Psychosocial Intervention Programme (iCanManage) on Outcomes of Patients With Colorectal Cancer and Their Family Caregivers
This study aims to develop a smartphone-based psychosocial intervention for patients with colorectal cancer and their family caregivers and to improve patients' confidence in self-care, psychological well-being, social support, quality of life, and satisfaction with care, as well as caregivers' burden, psychological well-being, and quality of life. The study also aims to explore patients' and their caregivers' perceptions of the intervention and routine care. A multi-centre two-arm experimental study design is used in this study. A total of 100 patient-caregiver dyads will be recruited and randomly allocated to either the control group (receiving routine care alone) or the intervention group (receiving routine care plus the psychosocial intervention). After completed the study, 15 patient-caregiver dyads will be invited for interviews to explore their perceptions on the intervention and/or routine care. This study will generate evidence on the effectiveness of the easily accessible and sustainable smartphone-based psychosocial intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
Other
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
Intervention group
description
Participants in the intervention group will receive an interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage) in addition to routine care provided by the respective hospitals.
interventionNames
Other: An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
type
NO_INTERVENTION
label
Control group
description
Participants in the control group will receive routine care provided by the respective hospitals . The routine care includes normal consultation with their attending physician, information concerning treatment plans, such as surgical procedures and its associated risks, preoperative preparations and postoperative care, treatment after discharge and/or subsequent adjunct therapy if required.
Primary outcomes (2)
measure
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
21 Years
Show eligibility criteria text
Inclusion Criteria:
* The inclusion criteria for patients are:
1. Aged 21 years old and above;
2. Diagnosed with primary colorectal cancer;
3. Scheduled for elective colorectal surgeries;
4. Able to read and speak English and/or Mandarin;
5. Have a smartphone with internet access; and
6. Have one identifiable main family caregiver
The inclusion criteria for caregivers include:
1. Aged 21 years old and above;
2. Main family caregiver of the patient
3. Able to read and speak English and/or Mandarin; and
4. Have a smartphone with internet access
Exclusion Criteria for both patients and caregivers:
1. visual or hearing impairments; and/or
2. cognitive impairments/mental disorders identified in their medical record
References
Publications (74)
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Colorectal cancer patients' self-efficacy
timeFrame
Patients' self-efficacy will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
The level of patient's self-efficacy will be measured by the 10-item General Self-Efficacy Scale (GSE). The General Self-Efficacy (GSE) Scale is a 4-point Likert scale (1 = not at all true, 2 = hardly true, 3 = moderately true, 4 = exactly true). The sum score ranges between 10 and 40 with a higher score indicating more self-efficacy.
measure
Caregivers' quality of life
timeFrame
Caregivers' quality of life will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
Caregivers' quality of life will be measured by 35-item Caregiver Quality of Life Index Cancer (CQOLC). Each item is scored from 0 (not at all) to 4 (very much). The total possible score is 140, with higher scores representing better quality of life.
Secondary outcomes (6)
measure
Patients' anxiety and depression
timeFrame
will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
Patients' anxiety and depression will be measured by the 14-item Hospital Anxiety and Depression scale (HADS). The Hospital Anxiety and Depression Scale comprises of 14-item self-report scale, 7 items for anxiety and 7 for depression. Each item on the HADS was scored on a four point (0-3) so the possible scores ranged from 0-21 for anxiety and 0-21 for depression. The scores of 8-10 in each scale may be suggestive of borderline risk of anxiety or depression and 11 or higher were indicative of probable 'caseness' of anxiety or depression (Pritchard, 2011; Snaith, 2003).
measure
Patients' Social support
timeFrame
Patients' social support will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
The level of patients social support will be measured by the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS). The Medical Outcomes Study Social Support Survey (MOS - SSS) measures four aspects of social support including (1) tangible support; (2) affectionate support; (3) positive social interaction and (4) emotional-informational support (Shebourne \& Stewart, 1991; Wang, Zheng, He, \& Thompson, 2013). Without regarding the source of support, the frequency of support available to each participant was captured through response indications from none-of-the-time (= 1) to all-of-the-time (= 5) on a 5-point scale. Tabulated scores for each dimension are then rescaled to a 0 to 100 range, where higher scores indicate higher support availability (McDowell, 2006).
measure
Patients' Health-related quality of life
timeFrame
Patients' health-related quality of life will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
Patients' health-related quality of life will be measured by the 29-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Colorectal cancer specific (EORTC QLQ-CR29). The EORTC QLQ-CR29 has 29 questions comprises of four functional scales and 18 symptoms scales. All the items are scored on a four-point Likert scale (1-4). Raw scores will be linearly transformed to a scale scores ranging from 0 to100 according to EORTC scoring manual (Fayers et al., 2001). A high scale score for functional scale represents a better functioning, while a high score for a symptom scale represents a worse symptom.
measure
Patients' Satisfaction with care
timeFrame
Patients' satisfaction with care will be assessed at baseline (around 2 weeks before surgery) ,and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
Patients' satisfaction with care will be measured by the 1-item 6-point Ordinal Descriptive Scale (ODS) from 1 (very dissatisfied) to 6 (very satisfied).
measure
Caregivers' burden
timeFrame
Caregivers' burden will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
Caregivers' burden will be measured by the 21-item Caregiver Reaction Assessment (CRA). The CRA contains subscales of self-esteem, family support, finances, schedule, and health. Each item is scored on a five-point Likert scale, ranging from strongly disagree (score 1) to strongly agree (score 5). The items constituting a particular subscale are averaged to generate subscale scores (ranging from 1 to 5). A higher score on the self-esteem subscale indicates a more positive effect of caregiving, higher scores on the other subscales indicate greater negative effects of caregiving in those domains.
measure
Caregivers' anxiety and depression
timeFrame
Caregivers' anxiety and depression will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery.
description
Caregivers' anxiety and depression will be measured by the 14-item Hospital Anxiety and Depression Scale (HADS). HADS comprises of 14-item self-report scale, 7 items for anxiety and 7 for depression. Each item on the HADS was scored on a four point (0-3) so the possible scores ranged from 0-21 for anxiety and 0-21 for depression. The scores of 8-10 in each scale may be suggestive of borderline risk of anxiety or depression and 11 or higher were indicative of probable 'caseness' of anxiety or depression (Pritchard, 2011; Snaith, 2003).
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DERIVEDWan SW, Chong CS, Toh EL, Lim SH, Loi CT, Lew YFH, Chua MCH, Jee XP, Liu G, Zhu L, Pikkarainen M, He HG. A Theory-Based, Multidisciplinary Approach to Cocreate a Patient-Centric Digital Solution to Enhance Perioperative Health Outcomes Among Colorectal Cancer Patients and Their Family Caregivers: Development and Evaluation Study. J Med Internet Res. 2021 Dec 7;23(12):e31917. doi: 10.2196/31917. PMID 34878991