Cope 360 App for Caregivers of Children With Cancer

NCT05112458 | Withdrawn

• 2 other identifiers: 110975K08CA230218-04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To date, most caregiver focused interventions have been targeted at caregivers of adults with cancer, completely ignoring the unique needs of caregivers of children with cancer. A recent meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced burden, improved ability to cope, increased self-efficacy, and improved aspects of caregivers' quality of life. Yet, several recent reviews highlighted a lack of interventions to provide practical skills for the day-to-day provision of care. The investigators have developed a pediatric oncology caregiver-focused intervention that seeks to improve caregiver clinical skills/knowledge, self-efficacy, and support seeking skills. Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. The investigators propose to evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).

Conditions

Pediatric Cancer

Keywords

mobile health; supportive care; adolescent; child; oncology

Outcome Measures

Primary Outcomes (7)

• Technology Feasibility Scale Rating

  Feasibility of participant use over an extended period of time; measured using the Technology Acceptance Model (TAM).

  6 months

• Qualitative Technology Feasibility

  Feasibility of participant use over an extended period of time; measured using semi-structured qualitative interviews.

  6 months

• Data Log User Acceptability

  Acceptability by caregivers in a real-world setting; measured using audits of usage data and recorded or reported errors from data logs.

  6 months

• Self-Efficacy Scale Rating

  Caregiver self-efficacy, measured using the Caregiver Self-Efficacy scale.

  6 months

• Mastery of Caregiving Scale Rating

  Mastery of caregiving skills/knowledge; measured using the the Caregiver Mastery scale.

  6 months

• Stress Reduction Scale Rating

  Reduction in caregiver stress; measured using the Pediatric Inventory for Parents assessment scale.

  6 months

• Healthcare Utilization Effect

  Effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).

  6 months

Study Arms (2)

Cope 360 application

EXPERIMENTAL

Participants are given access to the application and will use it to care for their child with cancer for a period of 6 months.

Other: Cope 360 mobile health application

Usual Care

ACTIVE COMPARATOR

Participants are given usual care and not given access to the application. They will be surveyed along with the experimental group for a period of 6 months.

Other: Usual care

Interventions

Cope 360 mobile health application OTHER

Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. We will evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).

Cope 360 application

Usual care OTHER

Caregivers of children with cancer will receive the usual clinical care provided to our patient population.

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking (app is in English)
• Caregiver (parent, legal guardian, grandparent, etc.) to a child with cancer
• Caregiver to a child with cancer currently undergoing therapy (chemotherapy, radiation, etc.)
• Caregiver to a child with cancer who anticipates therapy to continue for 6 months after recruitment
• Caregiver to a child with cancer between the ages of 0 and 21 years old
• Must own a smartphone or other internet capable mobile device

You may not qualify if:

• Non-English speaking (app is in English)
• Caregiver with a child with cancer who is not currently undergoing therapy
• Caregiver to a child with cancer who does not anticipate therapy to continue for 6 months after recruitment
• Caregiver with a child over age 21
• Caregiver who do not own a smartphone or other internet capable mobile device

Sponsors & Collaborators

• Indiana University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Emily L Mueller, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Half of the participants will receive the intervention and half will receive standard care. All will be assessed at enrollment, 1 month, 3 month, and 6 month time points.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: November 8, 2021
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share