Combined Effects of mHealth Psychoeducational and Benson Relaxation Technique Among Female Informal Caregivers of Cancer Patients in Bangladesh

NCT06204328 | Completed

• 1 other identifier: NUB/ DPH/EC 2023/ 26
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cancer is a global health concern that places a substantial burden not only on patients but also on their informal caregivers, often family members or close friends without formal medical training. Numerous studies show that caregivers face significant burdens, which impact their physical, social, and psychological well-being. Female caregivers, often subjected to cultural expectations, face heightened challenges, contributing to higher levels of burden and emotional distress. However, the combined effectiveness of Benson relaxation techniques and mHealth psychoeducational interventions on female informal caregivers of cancer patients remains relatively unexplored. Objective: This study aims to investigate the combined effectiveness of the mHealth psychoeducational intervention and Benson relaxation techniques to reducing caregiving burden as well as anxiety and depression, and to assess the impact on the quality of life among female informal caregivers of cancer patients in Bangladesh. Methods: A randomized control trial study will be conducted at the Khwaja Yunus Ali Medical College and Hospital in Enayetpur, Sirajganj, Bangladesh. Computer-generated simple random sampling technique will be used to select study participants. The study period will be from April 2024 to September 2024. Data will be collected through face-to-face interviews, employing validated tools such as Zarit Burden Interview, Hospital Anxiety Depression Scale, and Bangla WHOQOL-BREF. The intervention group will receive a combined intervention using self-determination theory (symptom management, maintaining and enhancing relationships, problem-solving, stress and coping, self-care, and effective communication) and Benson relaxation techniques through recorded videos, phone calls, and SMS reminders over six months. The control group will receive only usual care. The study ensures ethical practices, obtains informed consent, and prioritizes data safety and confidentiality. Results will be analyzed using statistical methods, which will provide valuable information for healthcare professionals, policymakers, and researchers in the field of cancer caregiving.

Conditions

Caregiver Burden

Keywords

Cancer; Caregiver; Care Burden; mHealth Psychoeducation; Benson Relaxation Technique; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Changes the caregiving burden among female informal caregivers of cancer patients in Bangladesh.

  The primary outcome will be evaluated by the Zarit Burden Interview scale. The Zarit Burden Interview scale consists of 22 items, and each item has a 5-point Likert scale ranging from 0 to 4, whereas higher scores represent higher burden.

  Baseline, 3 months (midline), and 6 months (endline) of intervention

Secondary Outcomes (2)

• Changes in caregivers' anxiety and depression of cancer patients.

  Baseline, 3 months (midline), and 6 months (endline) of intervention

• Measuring the changes in quality of life among caregivers of patients with cancer.

  Baseline, 3 months (midline), and 6 months (endline) of intervention

Study Arms (2)

Benson relaxation technique and mHealth psychoeducation

ACTIVE COMPARATOR

Intervention Group will receive 6 months mHealth psychoeducation \& Benson Relaxation Technique

Other: Benson relaxation technique and mHealth psychoeducation

Usual care

NO INTERVENTION

The usual care group will follow established and common practices by healthcare providers in these settings.

Interventions

Benson relaxation technique and mHealth psychoeducation OTHER

Benson relaxation technique \& mHealth psychoeducation (combined intervention) will receive: 6 months. Benson relaxation technique: Definition, benefits, and instruction about the Benson relaxation technique will be provided through recorded video, and a nurse will guide individuals face-to-face after receiving training from a physiotherapist. mHealth psychoeducation: There will be six sessions in a total of six months of intervention, and every session will be conducted at the beginning of each month. During each session, recorded videos based on the self-determination theory (symptom management, maintaining and enhancing relationships, problem-solving, stress and coping, self-care, and effective communication) will be provided face-to-face to the intervention group via smartphones, tablets, or handheld computers. As well as phone calls and SMS reminders will continue every week for follow-up and question and answer sessions.

Benson relaxation technique and mHealth psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who is facing caregiving burden in the baseline screening of the study.
• Female being 18 years of age or older.
• At least 6 months of providing care to a cancer-diagnosed patient.

You may not qualify if:

• Refusal to collaborate with ongoing study.
• Caregivers who receive financial compensation or are employed as formal caregivers.
• Extremely traumatic events that occur during the study (such as the death of loved ones or patients, separations, etc.) or caregivers undergoing treatment with psychotropic drugs will not be included in the study.
• Without smart mobile devices at home.

Sponsors & Collaborators

• Hiroshima University: lead

Study Sites (1)

Khwaja Yunus Ali Medical College Hospital

Sirajganj, Rajshahi Division, 6751, Bangladesh

Location

MeSH Terms

Conditions

Caregiver Burden; Neoplasms

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The computer-generated simple random sampling technique will be used to select the caregiving burden of study participants for both the intervention and control groups.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 12, 2024
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)