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

NCT ID: NCT04159363

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-01-31

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)

Intervention Type: OTHER

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

1. visual or hearing impairments; and/or

2. cognitive impairments/mental disorders identified in their medical record

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: collaborator

Singapore Cancer Society

OTHER

Sponsor Role: lead

Responsible Party

HE Hong-Gu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong-Gu HE, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Central Contacts

Hong-Gu HE, PhD

Role: CONTACT

nurhhg@nus.edu.sg

+6565167448

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Reference Type: DERIVED

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Related Links

https://www.aana.com/practice/clinical-practice-resources/enhanced-recovery-after-surgery

Enhanced Recovery after Surgery

https://www.nrdo.gov.sg/docs/librariesprovider3/default-document-library/cancertrends_7312_web128e09a5c9d76bafab5aff000014cdee.pdf?sfvrsn=0

Singapore Cancer Registry. Cancer Incidence and Mortality 2003 - 2012 and Selected Trends 1973-2012 In Singapore

https://www.who.int/publications-detail/cancer-control-diagnosis-and-treatment

World Health Organization (WHO). Cancer control: diagnosis and treatment.

Other Identifiers

SCS2018

Identifier Type: -

Identifier Source: org_study_id