Testis CancerPhase 2NCT04150848
A Biobehavioral Intervention for Young Men With Testicular Cancer
A Phase 2 study testing Goal-Focused Emotion Regulation Therapy (GET) and Individual Supportive Psychotherapy (ISP) in people with Testis Cancer, run by University of California, Irvine at 2 sites in United States.
Trial summary
This study is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in… Read more about this study
- Who is it for?
- Ages 18 to 39 years, men only
- Conditions the study is for
- Testis Cancer
- What is being tested?
- Goal-Focused Emotion Regulation Therapy (GET) and Individual Supportive Psychotherapy (ISP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2018to Dec 2021
- Phase
- Phase 2
- 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 to 39 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- between the ages of 18 and 39 years at the time of consent
- confirmed diagnosis of testis cancer (any stage)
- completed chemotherapy for testis cancer within 2 years prior to consent
- fluency in English (per self-report)
- sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)
Who cannot join
- lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
- active suicide plan
- disorder that compromises comprehension of assessments or informed consent information
- self-reported medical condition or medication use known to confound measures of systemic inflammation
- daily smoking
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of California, Irvine
Irvine, California, 92697-3957
Michael A Hoyt, PhD, 949-824-9937, mahoyt@uci.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10017
Attending Psychologist, nelsonc@mskcc.org
About this study
Official title: A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study
This study is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.
Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1) and twelve weeks after intervention at T2. Additionally, identified biomarkers will be measured at baseline and at T2.
- Conditions
- Testis Cancer
- Being tested
- Goal-Focused Emotion Regulation Therapy (GET), Individual Supportive Psychotherapy (ISP)
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Focused Emotion Regulation Therapy (GET)Behavioural
Six sessions delivered individually over 8 weeks
Individual Supportive Psychotherapy (ISP)Behavioural
Six sessions delivered individually over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Goal Focused Emotion-Regulation Therapy (GET) | Experimental | GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. GET has an emphasis on goal navigation skill building. This includes work on goal setting with a focus on assessing progress toward achieving specific, realistic, and measurable goals. Emotion regulation components include basic cognitive restructuring skills, cognitive distancing, and coping efficacy skills (matching the correct coping skill to specific circumstances). Receives: Behavioral: Goal-Focused Emotion Regulation Therapy (GET) |
| Individual Supportive Psychotherapy (ISP) | Active comparator | ISP includes 6-sessions of individual supportive psychotherapy and includes components of genuineness, unconditional positive regard, and empathic understanding through reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis. ISP emphasizes maintaining focus on the cancer experience, supporting participants in the "here and now," fostering expression of emotion and discussion of difficult topics, and creating a sense of being understood. Receives: Behavioral: Individual Supportive Psychotherapy (ISP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Anxiety and Depression Scale (HADS)
The HADS was developed to assess anxiety and depression in medical patients. It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment. The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer. The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales. Each item is rated on a 4-point response scale (from 0 to 3). Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical. A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.
Measured: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, CRP, sTNFαRII)
The investigators will focus on four biomarkers, IIL-6, IL-1ra, CRP, sTNFαRII, that indicate systemic inflammation and are associated with distress symptoms and emotion regulation. Levels will be assessed from plasma. Cytokine levels will be determined by immunosorbent assay (ELISA) according to assay manufacturer's protocols. All samples will be run in duplicate, and assays will be repeated on two separate days; intra-assay and interassay mean levels will be used in all analyses.
Measured: Change from Baseline (T0) at intrervention completion, an average of 8 weeks
Change in Salivary Diurnal Cortisol Slope and Daily Output
Diurnal rhythm in salivary cortisol will be measured over three days at each assessment. Participants will collect saliva samples in their natural environment upon awakening, 30 minutes later, 8 hours later, and at bedtime. Participants will complete a diary to assess relevant health behaviors (e.g., caffeine, tobacco, alcohol consumption; physical activity, sleep) as well as daily stress. They will be instructed to avoid brushing their teeth, eating, or drinking within 20 minutes before sampling. Participants will keep samples refrigerated prior to returning them to the research laboratory and returned salivettes will be stored in a -20-degree Celsius freezer until analyzed. After data collection is complete, salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay at the IISBR laboratory at UC Irvine. Several indices will be computed including diurnal slope, area under the daily curve, cortisol awakening response, and total daily cortisol output.
Measured: Change from Baseline (T0) at intrervention completion, an average of 8 weeks
Secondary outcomes (3)
Change in Emotion Regulation Questionnaire (ERQ) Scale Scores
Emotion regulation skills will be measured by the Emotion Regulation Questionnaire (ERQ). The ERQ is a widely used 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The ERQ is widely used in the context of clinical treatment trials and has well established validity, reliability, and factor structure (Goldin, Manber-Ball, Werner, Heimberg, \& Gross, 2009; Gross \& John, 2003).
Measured: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score
Goal navigation capacity includes elements of goal setting, goal clarification, goal adjustment, and goal initiation. It will be measured by the Goal Navigation subscale of the Cancer Assessment for Young Adults -Testicular (CAYA-T) (Hoyt et al., 2013). The scale is composed of five items (e.g., "I am able to identify goals in my life", "I know what steps to take to make progress toward my goals", and "I am able to redirect my energy when I feel my life isn't going in the right direction"). Participants indicate how often each item is true of them over the past 7 days on a 3-point response scale ranging from 0 (None of the time) to 2 (Much or most of the time). Criterion, construct, and procedural validity have been established with young adult testicular cancer survivors.
Measured: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Change in Career Thoughts Inventory (CTI) Global Score
The CTI (Sampson et al., 1996) is a 48-item self-administered instrument that measures an individual's level of dysfunctional thinking in career decision-making and career problem-solving. The CTI is normed on adults and broadly used in the context of I/O Psychology. Items are rated on a 4-point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree). CTI total score provides information about an individual's overall level of dysfunctional career thoughts, However, the CTI has three subscales: Decision-Making Confusion (difficulties with initiating or sustaining a career choice), Commitment Anxiety (difficulties with making a commitment to a career choice), and External Conflict (difficulties with balancing one's ideas with the ideas from others). The CTI has sound evidence for its content, construct, and criterion-related validity (Peila-Shuster \& Feller, 2013; Sampson et al., 1996).
Measured: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2018
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Testis CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150848
- Sponsor's protocol ID
- 2018-4676
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon request with permission of the investigation team.
Publications
Hoyt MA, Wang AW, Ceja RC, Cheavens JS, Daneshvar MA, Feldman DR, Funt SA, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study. Ann Behav Med. 2023 Aug 21;57(9):777-786. doi: 10.1093/abm/kaad010.
PubMed 37078969Hoyt MA, Wang AW, Ryan SJ, Breen EC, Cheavens JS, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. Trials. 2020 Apr 14;21(1):325. doi: 10.1186/s13063-020-04242-0.
PubMed 32290859
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT04150848
- Acronym / sponsor ID
- 2018-4676
- Conditions
- Testis Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Nov 2019 (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 is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.
Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1) and twelve weeks after intervention at T2. Additionally, identified biomarkers will be measured at baseline and at T2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Focused Emotion-Regulation Therapy (GET) | Experimental | Behavioral: Goal-Focused Emotion Regulation Therapy (GET)GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. GET has an emphasis on goal navigation skill building. This includes work on goal setting with a focus on assessing progress toward achieving specific, realistic, and measurable goals. Emotion regulation components include basic cognitive restructuring skills, cognitive distancing, and coping efficacy skills (matching the correct coping skill to specific circumstances). |
| Individual Supportive Psychotherapy (ISP) | Active comparator | Behavioral: Individual Supportive Psychotherapy (ISP)ISP includes 6-sessions of individual supportive psychotherapy and includes components of genuineness, unconditional positive regard, and empathic understanding through reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis. ISP emphasizes maintaining focus on the cancer experience, supporting participants in the "here and now," fostering expression of emotion and discussion of difficult topics, and creating a sense of being understood. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between the ages of 18 and 39 years at the time of consent
- confirmed diagnosis of testis cancer (any stage)
- completed chemotherapy for testis cancer within 2 years prior to consent
- fluency in English (per self-report)
- sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)
Key exclusion criteria (5 listed)
- lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
- active suicide plan
- disorder that compromises comprehension of assessments or informed consent information
- self-reported medical condition or medication use known to confound measures of systemic inflammation
- daily smoking
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 |
|---|---|---|
| Goal-Focused Emotion Regulation Therapy (GET)Six sessions delivered individually over 8 weeks | Behavioural | Goal Focused Emotion-Regulation Therapy (GET) |
| Individual Supportive Psychotherapy (ISP)Six sessions delivered individually over 8 weeks | Behavioural | Individual Supportive Psychotherapy (ISP) |
Primary outcome
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
The HADS was developed to assess anxiety and depression in medical patients. It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment. The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer. The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales. Each item is rated on a 4-point response scale (from 0 to 3). Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical. A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.
Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, CRP, sTNFαRII)
Time frame: Change from Baseline (T0) at intrervention completion, an average of 8 weeks
The investigators will focus on four biomarkers, IIL-6, IL-1ra, CRP, sTNFαRII, that indicate systemic inflammation and are associated with distress symptoms and emotion regulation. Levels will be assessed from plasma. Cytokine levels will be determined by immunosorbent assay (ELISA) according to assay manufacturer's protocols. All samples will be run in duplicate, and assays will be repeated on two separate days; intra-assay and interassay mean levels will be used in all analyses.
Change in Salivary Diurnal Cortisol Slope and Daily Output
Time frame: Change from Baseline (T0) at intrervention completion, an average of 8 weeks
Diurnal rhythm in salivary cortisol will be measured over three days at each assessment. Participants will collect saliva samples in their natural environment upon awakening, 30 minutes later, 8 hours later, and at bedtime. Participants will complete a diary to assess relevant health behaviors (e.g., caffeine, tobacco, alcohol consumption; physical activity, sleep) as well as daily stress. They will be instructed to avoid brushing their teeth, eating, or drinking within 20 minutes before sampling. Participants will keep samples refrigerated prior to returning them to the research laboratory and returned salivettes will be stored in a -20-degree Celsius freezer until analyzed. After data collection is complete, salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay at the IISBR laboratory at UC Irvine. Several indices will be computed including diurnal slope, area under the daily curve, cortisol awakening response, and total daily cortisol output.
3 secondary outcomes
Change in Emotion Regulation Questionnaire (ERQ) Scale Scores
Time frame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score
Time frame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Change in Career Thoughts Inventory (CTI) Global Score
Time frame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 37078969Hoyt MA, Wang AW, Ceja RC, Cheavens JS, Daneshvar MA, Feldman DR, Funt SA, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study. Ann Behav Med. 2023 Aug 21;57(9):777-786. doi: 10.1093/abm/kaad010.
- Derived from this study: PubMed 32290859Hoyt MA, Wang AW, Ryan SJ, Breen EC, Cheavens JS, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. Trials. 2020 Apr 14;21(1):325. doi: 10.1186/s13063-020-04242-0.
- Individual participant dataSharing planned: Undecided. Data will be shared upon request with permission of the investigation team.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Goal-Focused Emotion Regulation Therapy (GET) and Individual Supportive Psychotherapy (ISP) in people with Testis Cancer, run by University of California, Irvine at 2 sites in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Hoyt, PhD (949-824-9937, mahoyt@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale (HADS) (time frame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)). The study lists 3 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 NCT04150848, which also lists 2 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 19 Dec 2020.