Skip to main content
OpenTrials
Completed

NCT Number: NCT06745674

Online Intervention for Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility outcomes

    Time frame: Post-intervention (immediately after the 2-week intervention)

    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.

  2. Psychological Distress

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

    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.

  3. Anxiety and Depression

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

    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.

  4. Acceptability

    Time frame: Post-intervention (immediately after the 2-week intervention)

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Centrl China Normal University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.