NeoplasmNCT07729696
Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis
A study testing Digital psychoeducational intervention in people with Neoplasm and Cancer, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neoplasm, Cancer, Psychoeducational Intervention
- What is being tested?
- Digital psychoeducational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 24 Aug 2026to 14 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with cancer.
- Self-report fertility-related distress.
- Aged 18 to 40 years old.
- Able to speak Bahasa (the national language of Indonesia).
- Have a performance status ECOG score of 0-2.
Who cannot join
- Have a severe medical condition which impacts their level of consciousness.
- Diagnosed with a major psychiatric comorbidity.
- Unable to fill out the study questionnaires.
- Unable to decide to participate due to cognitive impairment, decreasing consciousness level, or difficulty verbalizing their wishes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Bali Mandara Genderal Hospital
Denpasar, Bali, 81113
Made Satya Nugraha Gautama, RN, M.Sc, +6282247469181, satyanugraha.g@gmail.com
About this study
Official title: Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. It will also assess how the intervention supports the development of effective coping strategies and social support networks. The main questions it aims to answer are: Does the digital psychoeducational intervention reduce anxiety and depression severity compared with usual care? Does the digital psychoeducational intervention increase patients' self-efficacy, social support, and coping compared with usual care? Does the digital psychoeducational intervention increase patients' quality of life compared with usual care? Researchers will compare the digital psychoeducational intervention to usual care (standard treatment) to see if the intervention effectively manages psychological problems and improves quality of life. Participants will:Be randomly assigned to either the experimental group or the control group. Attend an initial face-to-face introductory session, followed by four digital psychoeducational modules delivered via a mobile phone application (if assigned to the experimental group). Engage with module content including an e-booklet, video, and quizzes, with a new module opening every two days. Receive standard treatment from healthcare providers, and later receive the psychoeducational materials at the end of the data collection period (if assigned to the control group). Complete a series of validated questionnaires measuring depression, anxiety, coping, self-efficacy, social support, and quality of life at four different time points throughout the study.
Read the detailed description
Study Design and Framework This research will employ a four-stage design, culminating in a randomized controlled trial (RCT) based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The intervention's theoretical framework integrates Lazarus and Folkman's Coping Theory with Bandura's self-efficacy theory to address how young adult cancer patients cognitively and behaviorally manage illness-related challenges and fertility-related distress.
- Stage 1 (Literature Review): Identification of existing interventions to develop the digital psychoeducational framework.
- Stage 2 (Content Validity Testing): Assessment and revision of the intervention content by a seven-member expert panel comprising nursing experts, medical oncology specialists, head nurses, fertility specialists, and a clinical psychologist.
- Stage 3 (Intervention Trial): A pilot trial with 10 patients involving qualitative interviews to determine acceptability and comprehensiveness, followed by final program revisions.
- Stage 4 (RCT): The primary randomized controlled trial assessing the effectiveness of the finalized digital psychoeducational intervention.
Sample Size and Randomization The study will be conducted at the Oncology Inward Unit of Arifin Ahmad Hospital in Pekanbaru, Indonesia. The required sample size was calculated using G*Power based on an effect size of 0.81, alpha=5% (two-tailed), 90% power, and a 1:1 allocation ratio. Accounting for an anticipated 10% dropout rate, the targeted sample size is 38 patients per group. Eligible participants will be randomized into the experimental or control group using a lucky draw method, wherein patients independently select an unlabeled envelope to dictate their assignment.
Intervention Delivery and Monitoring Participants randomized to the experimental group will receive a digital psychoeducational intervention comprising an initial structured, in-person introduction followed by thematic modules delivered via a mobile application.
- Modules: The application features four modules focusing on cancer and fertility, coping skills development, self-efficacy, and social support.
- Format: Each module contains an e-booklet, a video, and quizzes, requiring approximately 35 to 50 minutes to complete in a single sitting.
- Pacing: Modules will be released sequentially; each must be open for two days before the subsequent module unlocks to encourage content practice.
- Engagement Features: The application includes automated motivational messaging, customizable daily reminders, and a direct messaging feature allowing patients to contact a counselor.
- Monitoring: The research team will track participant progress via application activity. Study staff will also conduct a follow-up phone call two weeks after the introductory session to troubleshoot technical difficulties, encourage engagement, and solicit verbal feedback.
Control Group Procedures Participants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period.
Data Collection Timeline
To mitigate bias, data will be collected by a blinded principal researcher and a trained research assistant. Researchers will administer surveys to both cohorts at four distinct time points:
- Upon study enrollment.
- Following the fourth module for the experimental group, or two weeks post-enrollment for the control group.
- Three weeks post-module completion for the experimental group, or five weeks post-enrollment for the control group.
- Twelve weeks post-module completion for the experimental group, or fourteen weeks post-enrollment for the control group.
During the second, third, and fourth collection periods, administrators will also query participants regarding any unrelated stressful or traumatic events to account for external factors impacting their wellbeing.
Statistical Analysis Plan Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 21, with a significance level set at P<0.05.
- Descriptive and Bivariate Analysis: Normal distribution will be verified via Kolmogorov-Smirnov and Shapiro-Wilk tests. Group differences will be evaluated using Independent T-tests or Mann-Whitney tests, depending on data distribution. Baseline categorical variables will be analyzed using Chi-square or Fisher's exact tests.
- Advanced Modeling: Generalized Estimating Equations (GEE) will be utilized for longitudinal analysis across the four time points.
- Missing Data Management: Strategies such as single and multiple imputation will be employed to manage anticipated missing data.
- Subgroup Analysis: A sub-analysis will stratify experimental participants by adherence levels, categorized as high or low activity. High activity is strictly defined as opening at least half the modules, accumulating a minimum of 20 minutes of total app usage, and completing 50% of the integrated quizzes.
- Conditions
- Neoplasm, Cancer, Psychoeducational Intervention, Young Adults, Fertility Outcomes, Psychological Distress
- Being tested
- Digital psychoeducational intervention, control group (standard of care + placebo).
- Medical subject headings
- Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital psychoeducational interventionBehavioural
The intervention is a guided digital psychoeducational program that begins with a face-to-face introductory session. Participants then use a specialized mobile application to complete four sequential thematic modules: Cancer and Fertility, Development of Coping Skills, Self-Efficacy, and Social Support. Each module features an e-booklet, a video, and interactive quizzes. To encourage the active practice of learned skills, the modules are time-locked, requiring a two-day interval before the next module becomes accessible. The application uniquely includes automated motivational messaging, customizable daily reminders, and a direct messaging portal connecting patients to a counselor. Additionally, study staff conduct a follow-up phone call two weeks after the introductory session to troubleshoot technical issues, monitor progress, and reinforce the practical application of the new coping and social support skills.
control group (standard of care + placebo).Behavioural
Participants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period. Receives: Behavioral: control group (standard of care + placebo). |
| Digital Psychoeducational Intervention Group | Experimental | The experimental group receives the digital psychoeducational intervention immediately Receives: Behavioral: Digital psychoeducational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Severity
Anxiety severity is measured using the Depression, Anxiety, and Stress Scale - Anxiety subscale (DASS-A). This subscale contains 14 questions utilizing a 4-point Likert scale ranging from 0 to 3. A higher score on this subscale indicates a higher severity of anxiety.
Measured: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Depression Severity
Depression severity is measured using the Depression, Anxiety, and Stress Scale - Depression subscale (DASS-D). The subscale contains 14 questions rated on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate a higher severity of depression.
Measured: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Coping
Coping is measured using the Brief Coping Orientation to Problems Experienced Inventory (Brief COPE). It contains 28 items rated on a 4-point Likert scale that explore 14 coping strategies, which are divided into problem-focused coping and emotional-focused coping. A higher score represents greater coping strategies used by respondents.
Measured: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Self-Efficacy
Self-efficacy is measured using the Cancer Behavior Inventory (CBI-B V1.0-12). It consists of 12 questions with a scale range of 1 to 9, where 1 is absolutely not sure and 9 is absolutely sure. A higher score indicates higher self-efficacy when dealing with cancer.
Measured: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Secondary outcomes (1)
Quality of life - Functional Assessment of Cancer Therapy-G (FACT-G)
Quality of life is measured using the Functional Assessment of Cancer Therapy-G (FACT-G). The FACT-G consists of 27 items divided into 4 primary domains: physical wellbeing, social/family wellbeing, emotional wellbeing, and functional wellbeing. The total score is obtained by summing individual subscale scores, with a higher score indicating a higher quality of life.
Measured: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start24 Aug 2026 (estimated)
- Primary completion7 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a randomized controlled trial (RCT) design based on CONSORT guidelines to evaluate a digital psychoeducational intervention. Participants are assigned to an experimental or control group in a 1:1 ratio using a randomized "lucky draw" method, where patients choose an unlabeled envelope. The trial utilizes a parallel-group, waitlist-control model. The experimental group immediately receives the digital intervention, while the control group receives standard care throughout the data collection period. To ensure equity, the control group receives the psychoeducational materials after data collection concludes. To minimize bias, the principal researcher and research assistant are strictly blinded to group allocations during data collection. Furthermore, the head nurse assisting with recruitment remains blinded to assignments to prevent influencing patient consent.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Riau, Bali Mandara Hospital, Denpasar, Bali, Indonesia
- Responsible party
- Principal investigator, Made Satya Nugraha Gautama, Universitas Riau
- Investigators
- Nurul Huda, RN, PhD, Principal investigator, Universitas RiauMalissa Kay Shaw, PhD, Principal investigator, University of Health Sciences and Pharmacy in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729696
- Sponsor's protocol ID
- 2118
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huda N, Lin YK, Shaw MK, Hsu YY, Chang HJ. Psychometric properties and cross-cultural adaptation of the Indonesian version of the Brief COPE in a sample of advanced cancer patients. PLoS One. 2022 Nov 28;17(11):e0275083. doi: 10.1371/journal.pone.0275083. eCollection 2022.
PubMed 36441773Benedict C, Shuk E, Ford JS. Fertility Issues in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):48-57. doi: 10.1089/jayao.2015.0024. Epub 2015 Nov 18.
PubMed 26812452Allison KR, Patterson P, Ussher JM, McDonald FEJ, Perz J. Evaluating Maybe Later Baby, a Fertility Information Resource for Adolescents and Young Adults Diagnosed with Cancer: A Randomized, Controlled Pilot Study. J Adolesc Young Adult Oncol. 2023 Feb;12(1):101-109. doi: 10.1089/jayao.2021.0206. Epub 2022 Mar 24.
PubMed 35333618
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07729696
- Acronym / sponsor ID
- 2118
- Conditions
- Neoplasm, Cancer, Psychoeducational Intervention, Young Adults, Fertility Outcomes, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Universitas Riau, Bali Mandara Hospital, Denpasar, Bali, Indonesia
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 7 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 27 Jul 2026 (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.
The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. It will also assess how the intervention supports the development of effective coping strategies and social support networks. The main questions it aims to answer are: Does the digital psychoeducational intervention reduce anxiety and depression severity compared with usual care? Does the digital psychoeducational intervention increase patients' self-efficacy, social support, and coping compared with usual care? Does the digital psychoeducational intervention increase patients' quality of life compared with usual care? Researchers will compare the digital psychoeducational intervention to usual care (standard treatment) to see if the intervention effectively manages psychological problems and improves quality of life. Participants will:Be randomly assigned to either the experimental group or the control group. Attend an initial face-to-face introductory session, followed by four digital psychoeducational modules delivered via a mobile phone application (if assigned to the experimental group). Engage with module content including an e-booklet, video, and quizzes, with a new module opening every two days. Receive standard treatment from healthcare providers, and later receive the psychoeducational materials at the end of the data collection period (if assigned to the control group). Complete a series of validated questionnaires measuring depression, anxiety, coping, self-efficacy, social support, and quality of life at four different time points throughout the study.
Detailed description
Study Design and Framework This research will employ a four-stage design, culminating in a randomized controlled trial (RCT) based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The intervention's theoretical framework integrates Lazarus and Folkman's Coping Theory with Bandura's self-efficacy theory to address how young adult cancer patients cognitively and behaviorally manage illness-related challenges and fertility-related distress.
- Stage 1 (Literature Review): Identification of existing interventions to develop the digital psychoeducational framework.
- Stage 2 (Content Validity Testing): Assessment and revision of the intervention content by a seven-member expert panel comprising nursing experts, medical oncology specialists, head nurses, fertility specialists, and a clinical psychologist.
- Stage 3 (Intervention Trial): A pilot trial with 10 patients involving qualitative interviews to determine acceptability and comprehensiveness, followed by final program revisions.
- Stage 4 (RCT): The primary randomized controlled trial assessing the effectiveness of the finalized digital psychoeducational intervention.
Sample Size and Randomization The study will be conducted at the Oncology Inward Unit of Arifin Ahmad Hospital in Pekanbaru, Indonesia. The required sample size was calculated using G*Power based on an effect size of 0.81, alpha=5% (two-tailed), 90% power, and a 1:1 allocation ratio. Accounting for an anticipated 10% dropout rate, the targeted sample size is 38 patients per group. Eligible participants will be randomized into the experimental or control group using a lucky draw method, wherein patients independently select an unlabeled envelope to dictate their assignment.
Intervention Delivery and Monitoring Participants randomized to the experimental group will receive a digital psychoeducational intervention comprising an initial structured, in-person introduction followed by thematic modules delivered via a mobile application.
- Modules: The application features four modules focusing on cancer and fertility, coping skills development, self-efficacy, and social support.
- Format: Each module contains an e-booklet, a video, and quizzes, requiring approximately 35 to 50 minutes to complete in a single sitting.
- Pacing: Modules will be released sequentially; each must be open for two days before the subsequent module unlocks to encourage content practice.
- Engagement Features: The application includes automated motivational messaging, customizable daily reminders, and a direct messaging feature allowing patients to contact a counselor.
- Monitoring: The research team will track participant progress via application activity. Study staff will also conduct a follow-up phone call two weeks after the introductory session to troubleshoot technical difficulties, encourage engagement, and solicit verbal feedback.
Control Group Procedures Participants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period.
Data Collection Timeline
To mitigate bias, data will be collected by a blinded principal researcher and a trained research assistant. Researchers will administer surveys to both cohorts at four distinct time points:
- Upon study enrollment.
- Following the fourth module for the experimental group, or two weeks post-enrollment for the control group.
- Three weeks post-module completion for the experimental group, or five weeks post-enrollment for the control group.
- Twelve weeks post-module completion for the experimental group, or fourteen weeks post-enrollment for the control group.
During the second, third, and fourth collection periods, administrators will also query participants regarding any unrelated stressful or traumatic events to account for external factors impacting their wellbeing.
Statistical Analysis Plan Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 21, with a significance level set at P<0.05.
- Descriptive and Bivariate Analysis: Normal distribution will be verified via Kolmogorov-Smirnov and Shapiro-Wilk tests. Group differences will be evaluated using Independent T-tests or Mann-Whitney tests, depending on data distribution. Baseline categorical variables will be analyzed using Chi-square or Fisher's exact tests.
- Advanced Modeling: Generalized Estimating Equations (GEE) will be utilized for longitudinal analysis across the four time points.
- Missing Data Management: Strategies such as single and multiple imputation will be employed to manage anticipated missing data.
- Subgroup Analysis: A sub-analysis will stratify experimental participants by adherence levels, categorized as high or low activity. High activity is strictly defined as opening at least half the modules, accumulating a minimum of 20 minutes of total app usage, and completing 50% of the integrated quizzes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a randomized controlled trial (RCT) design based on CONSORT guidelines to evaluate a digital psychoeducational intervention. Participants are assigned to an experimental or control group in a 1:1 ratio using a randomized "lucky draw" method, where patients choose an unlabeled envelope. The trial utilizes a parallel-group, waitlist-control model. The experimental group immediately receives the digital intervention, while the control group receives standard care throughout the data collection period. To ensure equity, the control group receives the psychoeducational materials after data collection concludes. To minimize bias, the principal researcher and research assistant are strictly blinded to group allocations during data collection. Furthermore, the head nurse assisting with recruitment remains blinded to assignments to prevent influencing patient consent.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: control group (standard of care + placebo).Participants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period. |
| Digital Psychoeducational Intervention Group | Experimental | Behavioral: Digital psychoeducational interventionThe experimental group receives the digital psychoeducational intervention immediately |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with cancer.
- Self-report fertility-related distress.
- Aged 18 to 40 years old.
- Able to speak Bahasa (the national language of Indonesia).
- Have a performance status ECOG score of 0-2.
Key exclusion criteria (4 listed)
- Have a severe medical condition which impacts their level of consciousness.
- Diagnosed with a major psychiatric comorbidity.
- Unable to fill out the study questionnaires.
- Unable to decide to participate due to cognitive impairment, decreasing consciousness level, or difficulty verbalizing their wishes.
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 |
|---|---|---|
| Digital psychoeducational interventionThe intervention is a guided digital psychoeducational program that begins with a face-to-face introductory session. Participants then use a specialized mobile application to complete four sequential thematic modules: Cancer and Fertility, Development of Coping Skills, Self-Efficacy, and Social Support. Each module features an e-booklet, a video, and interactive quizzes. To encourage the active practice of learned skills, the modules are time-locked, requiring a two-day interval before the next module becomes accessible. The application uniquely includes automated motivational messaging, customizable daily reminders, and a direct messaging portal connecting patients to a counselor. Additionally, study staff conduct a follow-up phone call two weeks after the introductory session to troubleshoot technical issues, monitor progress, and reinforce the practical application of the new coping and social support skills. | Behavioural | Digital Psychoeducational Intervention Group |
| control group (standard of care + placebo).Participants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period. | Behavioural | Control Group |
Primary outcome
Anxiety Severity
Time frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Anxiety severity is measured using the Depression, Anxiety, and Stress Scale - Anxiety subscale (DASS-A). This subscale contains 14 questions utilizing a 4-point Likert scale ranging from 0 to 3. A higher score on this subscale indicates a higher severity of anxiety.
Depression Severity
Time frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Depression severity is measured using the Depression, Anxiety, and Stress Scale - Depression subscale (DASS-D). The subscale contains 14 questions rated on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate a higher severity of depression.
Coping
Time frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Coping is measured using the Brief Coping Orientation to Problems Experienced Inventory (Brief COPE). It contains 28 items rated on a 4-point Likert scale that explore 14 coping strategies, which are divided into problem-focused coping and emotional-focused coping. A higher score represents greater coping strategies used by respondents.
Self-Efficacy
Time frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Self-efficacy is measured using the Cancer Behavior Inventory (CBI-B V1.0-12). It consists of 12 questions with a scale range of 1 to 9, where 1 is absolutely not sure and 9 is absolutely sure. A higher score indicates higher self-efficacy when dealing with cancer.
1 secondary outcome
Quality of life - Functional Assessment of Cancer Therapy-G (FACT-G)
Time frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 36441773Huda N, Lin YK, Shaw MK, Hsu YY, Chang HJ. Psychometric properties and cross-cultural adaptation of the Indonesian version of the Brief COPE in a sample of advanced cancer patients. PLoS One. 2022 Nov 28;17(11):e0275083. doi: 10.1371/journal.pone.0275083. eCollection 2022.
- Background: PubMed 26812452Benedict C, Shuk E, Ford JS. Fertility Issues in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):48-57. doi: 10.1089/jayao.2015.0024. Epub 2015 Nov 18.
- Background: PubMed 35333618Allison KR, Patterson P, Ussher JM, McDonald FEJ, Perz J. Evaluating Maybe Later Baby, a Fertility Information Resource for Adolescents and Young Adults Diagnosed with Cancer: A Randomized, Controlled Pilot Study. J Adolesc Young Adult Oncol. 2023 Feb;12(1):101-109. doi: 10.1089/jayao.2021.0206. Epub 2022 Mar 24.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nurul Huda, RN, PhD principal investigator
Universitas Riau
Malissa Kay Shaw, PhD principal investigator
University of Health Sciences and Pharmacy in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital psychoeducational intervention in people with Neoplasm and Cancer, run by Gadjah Mada University at 1 site in Indonesia.
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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurul Huda, RN, PhD (+62 82312213660, nurulmamaifda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Severity (time frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment.). 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?
On the ClinicalTrials.gov record for NCT07729696, which also lists 3 linked publications.
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 27 Jul 2026.