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Colorectal CanceriCanManageNCT04159363

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

A study testing An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage) in people with Colorectal Cancer, run by Singapore Cancer Society.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 Feb 2020to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The inclusion criteria for patients are:
  • Aged 21 years old and above;
  • Diagnosed with primary colorectal cancer;
  • Scheduled for elective colorectal surgeries;
  • Able to read and speak English and/or Mandarin;
  • Have a smartphone with internet access; and
Show all 12Show fewer
  • Have one identifiable main family caregiver
  • The inclusion criteria for caregivers include:
  • Aged 21 years old and above;
  • Main family caregiver of the patient
  • Able to read and speak English and/or Mandarin; and
  • Have a smartphone with internet access

Who cannot join

  • visual or hearing impairments; and/or
  • cognitive impairments/mental disorders identified in their medical record

Trial locations and contacts

No sites are listed yet.

Hong-Gu HE, PhD contact

+6565167448

nurhhg@nus.edu.sg

About this study

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

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.

Read the 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.
Being tested
An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
Keywords
psychosocial intervention, smartphone-based, patient, colorectal cancer, caregiver, randomised controlled trial
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04159363
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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.
Receives: Other: An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
Control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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 outcomes (6)

  1. 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).

    Measured: 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.

  2. 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).

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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).

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2019
  2. Study start1 Feb 2020 (estimated)
  3. Primary completion31 Jan 2021 (estimated)
  4. Study completion31 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04159363
Sponsor's protocol ID
SCS2018
Acronym
iCanManage
Status last verified
Nov 2019
First submitted
15 Oct 2019
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data will only be available for researchers involved in this study.

Publications

  • Al Daken LI, Ahmad MM. The implementation of mindfulness-based interventions and educational interventions to support family caregivers of patients with cancer: A systematic review. Perspect Psychiatr Care. 2018 Jul;54(3):441-452. doi: 10.1111/ppc.12286. Epub 2018 May 10.

    PubMed 29745417

  • Ang SG, Chen HC, Siah RJ, He HG, Klainin-Yobas P. Stressors relating to patient psychological health following stoma surgery: an integrated literature review. Oncol Nurs Forum. 2013 Nov;40(6):587-94. doi: 10.1188/13.ONF.587-594.

    PubMed 24161637

  • Badr H, Lipnick D, Diefenbach MA, Posner M, Kotz T, Miles B, Genden E. Development and usability testing of a web-based self-management intervention for oral cancer survivors and their family caregivers. Eur J Cancer Care (Engl). 2016 Sep;25(5):806-21. doi: 10.1111/ecc.12396. Epub 2015 Oct 27.

    PubMed 26507369

  • Badr H, Carmack CL, Diefenbach MA. Psychosocial interventions for patients and caregivers in the age of new communication technologies: opportunities and challenges in cancer care. J Health Commun. 2015;20(3):328-42. doi: 10.1080/10810730.2014.965369. Epub 2015 Jan 28.

    PubMed 25629218

  • Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: Freeman.

  • Bazaliński, D., Salacinska, I., Wiech, P. & Kozka, M. (2014). Life satisfaction and self-efficacy in patients with stoma. Progress in Health Sciences, 4(2), 22-30.

  • Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.

    PubMed 15367063

  • Bevans M, Sternberg EM. Caregiving burden, stress, and health effects among family caregivers of adult cancer patients. JAMA. 2012 Jan 25;307(4):398-403. doi: 10.1001/jama.2012.29.

    PubMed 22274687

  • Butler DL. Early postoperative complications following ostomy surgery: a review. J Wound Ostomy Continence Nurs. 2009 Sep-Oct;36(5):513-9; quiz 520-1. doi: 10.1097/WON.0b013e3181b35eaa.

    PubMed 19752661

  • Raingruber B. The effectiveness of psychosocial interventions with cancer patients: an integrative review of the literature (2006-2011). ISRN Nurs. 2011;2011:638218. doi: 10.5402/2011/638218. Epub 2011 Nov 16.

    PubMed 22191052

  • Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007 Aug;42(4):1758-72. doi: 10.1111/j.1475-6773.2006.00684.x.

    PubMed 17286625

  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101.

  • Carlson, L., & Speca, M. (2011). Mindfulness-Based Cancer Recovery: A step-by-step MBSR Approach to help you cope with treatment & reclaim your life. Oakland, CA: New Harbinger Publications.

  • Carter PA. A brief behavioral sleep intervention for family caregivers of persons with cancer. Cancer Nurs. 2006 Mar-Apr;29(2):95-103. doi: 10.1097/00002820-200603000-00003.

    PubMed 16565618

  • Chawla N, Butler EN, Lund J, Warren JL, Harlan LC, Yabroff KR. Patterns of colorectal cancer care in Europe, Australia, and New Zealand. J Natl Cancer Inst Monogr. 2013;2013(46):36-61. doi: 10.1093/jncimonographs/lgt009.

    PubMed 23962509

Questions about this trial

What is this clinical trial studying?

A study testing An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage) in people with Colorectal Cancer, run by Singapore Cancer Society.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hong-Gu HE, PhD (+6565167448, nurhhg@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colorectal cancer patients' self-efficacy (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04159363, which also lists 74 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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