CancerNCT06745674
Online Intervention for Cancer Patients
A study testing a mobile app-delivered Acceptance Commitment Therapy (ACT) in people with Cancer, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- a mobile app-delivered Acceptance Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- a mobile app-delivered Acceptance Commitment Therapy (ACT)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a mobile app-delivered Acceptance Commitment Therapy (ACT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control group | No intervention | Not described |
| ACT group | Experimental | Not described Receives: Behavioral: a mobile app-delivered Acceptance Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (immediately after the 2-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Central China Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745674
- Sponsor's protocol ID
- IRB-202311017b
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-based Acceptance and Commitment Therapy for Cancer Patients: A Pilot Randomized Controlled Trial Using Mixed Methods
- ClinicalTrials.gov ID
- NCT06745674
- Acronym / sponsor ID
- IRB-202311017b
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Central China Normal University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control group | No intervention | – |
| ACT group | Experimental | Behavioral: a mobile app-delivered Acceptance Commitment Therapy (ACT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a mobile app-delivered Acceptance Commitment Therapy (ACT) in people with Cancer, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcomes (time frame: Post-intervention (immediately after the 2-week intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.