A Psychosocial Intervention for Patients With Colorectal Cancer and Their Family Caregivers

Colorectal Cancer Clinical Trial

— iCanManage  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04159363
• Other study ID #: SCS2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2019
• Source: Singapore Cancer Society
• Contact: Hong-Gu HE, PhD
• Phone: +6565167448
• Email: nurhhg[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. Aims The aims of the study are: (1) To develop an interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage program); (2) To examine the effectiveness of iCanManage for colorectal cancer patients and their caregivers in improving patients' health outcomes including self-efficacy (primary outcome), psychological well-being (anxiety & depression), social support, health-related quality of life (HRQoL) and satisfaction with care, as well as caregivers' burden, psychological well-being, and quality of life (QoL) (primary outcome); and (3) To explore patients' and their caregivers' perceptions of iCanManage and routine care.

2. Hypotheses Over 3 months' follow-up, compared to patients in the control group,patients who receive iCanManage in addition to hospital routine care will report significantly: (1) higher levels of self-efficacy, social support, HRQoL and satisfaction with care, and (2) lower levels of anxiety and depression; whilst caregivers will report significantly lower levels of burden, anxiety and depression, and higher level of QoL.

3. Methodology A multi-centre two-arm randomised controlled trial will be conducted at two public hospitals in Singapore. A total of 100 patient-caregiver dyads will be recruited via convenience sampling. Participants (patient-caregiver dyads) will be randomly allocated to either the intervention (receiving iCanManage in addition to hospital routine care) or the control group (receiving only hospital routine care). The aforementioned outcomes of both patients and caregivers will be measured at baseline (start of access to iCanManage), 2-weeks post-surgery (end of access to iCanManage) and 3-months post-surgery. Descriptive statistics, repeated measures analysis of covariance, univariate analysis of covariance (ANCOVA) will be used to analyse the data. At the end of the trial, semi-structured interviews will be conducted to explore 30 patients' and 30 caregivers' perceptions on iCanManage and or routine care. The transcribed interview data will be analysed using a thematic analysis.

4. Significance of the study This study will generate evidence on the effectiveness of the easily accessible and sustainable iCanManage. Should the quantitative and qualitative findings support the feasibility and effects of the intervention, it can be adopted by hospital policymakers as added routine care to enhance patients' self-management ability throughout their surgery journey.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
The iCanManage consists of two components: (1a) Existing functions from the BuddyCare mobile application that provide a comprehensive 29 day-by-day perioperative guide for patients who will be undergoing colorectal elective surgery; (1b) a dashboard for healthcare professionals to monitor patients and their caregivers' well-being as well as allow mutual communication; and (2) Newly developed digitalised psychosocial content (e.g., mindfulness-based activities with audio cover, video materials related to positive psychology, patient ambassadors' success stories and relevant psychoeducation) tailored for colorectal cancer patients and caregivers, with the aim of providing them emotional and psychosocial support.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Singapore Cancer Society	National University Hospital, Singapore, Singapore General Hospital

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* Note: There are 73 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer patients' self-efficacy	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.	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.
Primary	Caregivers' quality of life	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.	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.
Secondary	Patients' anxiety and depression	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).	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.
Secondary	Patients' Social support	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).	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.
Secondary	Patients' Health-related quality of life	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.	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.
Secondary	Patients' Satisfaction with care	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).	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.
Secondary	Caregivers' burden	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.	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.
Secondary	Caregivers' anxiety and depression	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).	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.

External Links

•   Enhanced Recovery after Surgery
•   National Cancer Centre Singapore. Support Groups
•   nfocomm Media Development Authority (IMDA)
•   Singapore Cancer Registry. Cancer Incidence and Mortality 2003 - 2012 and Selected Trends 1973-2012 In Singapore
•   World Health Organization (WHO). Cancer control: diagnosis and treatment.