Online Intervention for Cancer Patients

Effectiveness of Internet-based Acceptance and Commitment Therapy for Cancer Patients: A Pilot Randomized Controlled Trial Using Mixed Methods

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: a mobile app-delivered Acceptance Commitment Therapy (ACT)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist control group
Experimental: ACT group	Behavioral: a mobile app-delivered Acceptance Commitment Therapy (ACT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Centrl China Normal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-202311017b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No