Online Intervention for Cancer Patients

NCT06745674 | Completed

• 1 other identifier: IRB-202311017b
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus on supporting cancer patients who often experience emotional challenges like anxiety and depression. It will test a two-week online program called Acceptance and Commitment Therapy (ACT), designed to help people manage difficult emotions and focus on what matters most in their lives. The program will include short, easy-to-follow sessions covering helpful strategies like accepting distress and staying present in the moment. Participants will be randomly assigned to either join the ACT program or wait for the program while continuing their usual care. The study aims to determine whether the ACT program can reduce psychological distress, anxiety, and depression in cancer patients. The study will use a mixed-methods approach, combining both quantitative data (such as changes in distress, anxiety, and depression) and qualitative insights from participant interviews. This will help us gain a deeper understanding of how the ACT program may support the psychological distress of cancer patients.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• Feasibility outcomes

  Feasibility is evaluated using retention rate and intervention completion rate. Retention rate reflects the percentage of participants who successfully completed all study-related measurements throughout the trial.

  Post-intervention (immediately after the 2-week intervention)

• Psychological Distress

  Psychological distress is assessed using the Distress Thermometer (DT) (Holland et al., 2013). Scores range from 0 (no distress) to 10 (extreme distress), with higher scores reflecting greater levels of psychological distress.

  Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)

• Anxiety and Depression

  Anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983), a 14-item questionnaire comprising separate subscales for anxiety and depression. Each item is scored on a 4-point Likert scale, and higher scores reflect greater severity of anxiety and depression symptoms.

  Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)

• Acceptability

  Acceptability is evaluated using the Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979). This 8-item measure uses a 4-point Likert scale (1 = low satisfaction to 4 = high satisfaction), with higher scores indicating greater satisfaction with the treatment.

  Post-intervention (immediately after the 2-week intervention)

Study Arms (2)

Waitlist control group

NO INTERVENTION

ACT group

EXPERIMENTAL

Behavioral: a mobile app-delivered Acceptance Commitment Therapy (ACT)

Interventions

a mobile app-delivered Acceptance Commitment Therapy (ACT) BEHAVIORAL

The study utilized a specially tailored internet-based self-help ACT program for cancer patients. It consisted of an introductory module and six core intervention modules: (1) Refusing Avoidance; (2) Accepting Distress; (3) Living in the Present Moment; (4) Observing Yourself Psychologically; (5) Exploring Meaningful Values; and (6) Committing to Action. Each module, designed to take 30-60 minutes, was delivered over a two-week period.

ACT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 and above;
• diagnosed cancer with a clear disease course
• fluent in Chinese with the ability to read and understand questionnaires independently;
• ability to operate a smartphone independently;
• not participating in or intervening in other clinical studies.

You may not qualify if:

• younger than 18 years of age
• unable to use a smartphone
• have significant cognitive impairment or a serious systemic disease or psychiatric disorder
• concurrently participating in other clinical studies or undergoing other psychotherapy

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Centrl China Normal University: collaborator

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)