Hematopoietic and Lymphoid System NeoplasmNCT04436835
Psychotherapy (Accelerated Resolution Therapy) for Cancer Related Trauma and Distress
A study testing Psychotherapy and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This trial studies whether a form of psychotherapy called accelerated resolution therapy can help with cancer distress and psychological trauma. Accelerated resolution therapy is an evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Psychotherapy and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2019to 19 Aug 2021
- 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
- Able to read, write and understand English
- Undergone chemotherapy, radiation therapy, chimeric antigen receptor T cells (CAR-T), or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer
- A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time)
- A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
- Denial of suicidal ideation or intent, with no evidence of psychotic behavior
- Participants must be willing and able to utilize secure web conferencing software, phone calls, or to travel to Mayo Clinic outside of normally scheduled visits to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Accelerated Resolution Therapy for Cancer Related Trauma and Distress: a Pilot Study
This trial studies whether a form of psychotherapy called accelerated resolution therapy can help with cancer distress and psychological trauma. Accelerated resolution therapy is an evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related disorders. This study may provide evidence to support integration of accelerated resolution therapy into psychological treatment of cancer patients, which may decrease cancer related trauma and distress.
Read the detailed description
PRIMARY OBJECTIVES:
- Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma and cancer distress over a six week time period while receiving weekly accelerated resolution therapy (ART).
II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and depression over a six week period while receiving weekly ART.
III. Will use a qualitative, descriptive design to explore contextual elements of the cancer experience that are consistently distressing and/or psychologically traumatic to more fully inform a future RCT testing in ART in cancer distress and psychological trauma.
IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and symptom distress over a six week period while receiving weekly ART.
OUTLINE:
Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.
After completion of study intervention, patients are followed up at 1 week and again at 1 month.
- Being tested
- Psychotherapy, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Also called talk therapy
Undergo ART
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (ART) | Experimental | Patients undergo ART over 60-90 minutes once a week for up to 5 sessions. Receives: Behavioral: Psychotherapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological trauma
Symptoms of psychological trauma will be measured with both the Primary Care-Post Traumatic Stress Disorder Screening (PC-PTSD-5) and the Post Traumatic Stress Disorder Checklist (PCL-5). The PCL-5 (PTSD Patient Checklist) is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma). The total symptom severity score ranges from 0 to 80.
Measured: Up to 6 weeks
Cancer distress
Cancer distress will be measured with the Cancer Treatment Distress Scale (CTxD). The CTxD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience.
Measured: Up to 6 weeks
Secondary outcomes (4)
Anxiety
The General Anxiety Disorder (GAD-7) is a measure of anxiety scored from 0 (not at all)-3 (nearly every day) scale for each item with total scores ranging from 0-21. A score of 10 or more indicates high anxiety, although a cut-score of 7 or higher has been suggested for cancer populations.
Measured: Up to 6 weeks
Depression
The Patient Health Questionnaire (PHQ-8) is an 8 item measure of depression scoring DSM -IV criteria for depression on a 0 (not at all) to 3 (nearly every day) scale for each item with total scores ranging from 0-24 (25). A score of 10 or more indicates depression.
Measured: Up to 6 weeks
Resilience
The Connor-Davidson Resilience Scale (CD-RISC) is a 10 item scale in which participants rate statements on a scale of 0 (not at all true) to 4 (true nearly all the time). Higher scores indicate higher levels of resilience.
Measured: Up to 6 weeks
Symptom distress
The Edmonton Symptom Assessment Scale (ESAS) consists of 11-point numerical rating scales for self-report of ten common symptoms of cancer. A summary score is calculated with higher scores representing greater symptom distress.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start27 Nov 2019
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Tofthagen, Mayo Clinic
- Investigators
- Cindy Tofthagen, Ph.D., R.N., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436835
- Sponsor's protocol ID
- 19-006093
- Other IDs
- NCI-2020-04130, 19-006093
- Status last verified
- Dec 2024
- First submitted
- 16 Jun 2020
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tofthagen C, Donovan KA, Mandrekar J, Buck HG. Accelerated Resolution Therapy for Cancer Distress and Post-Traumatic Stress Symptoms: Results of a Pilot Study. Psychooncology. 2025 Jan;34(1):e70058. doi: 10.1002/pon.70058.
PubMed 39902953
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Resolution Therapy for Cancer Related Trauma and Distress: a Pilot Study
- ClinicalTrials.gov ID
- NCT04436835
- Acronym / sponsor ID
- 19-006093
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 18 Jun 2020 (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 trial studies whether a form of psychotherapy called accelerated resolution therapy can help with cancer distress and psychological trauma. Accelerated resolution therapy is an evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related disorders. This study may provide evidence to support integration of accelerated resolution therapy into psychological treatment of cancer patients, which may decrease cancer related trauma and distress.
Detailed description
PRIMARY OBJECTIVES:
- Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma and cancer distress over a six week time period while receiving weekly accelerated resolution therapy (ART).
II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and depression over a six week period while receiving weekly ART.
III. Will use a qualitative, descriptive design to explore contextual elements of the cancer experience that are consistently distressing and/or psychologically traumatic to more fully inform a future RCT testing in ART in cancer distress and psychological trauma.
IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and symptom distress over a six week period while receiving weekly ART.
OUTLINE:
Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.
After completion of study intervention, patients are followed up at 1 week and again at 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (ART) | Experimental | Behavioral: Psychotherapy, Other: Questionnaire AdministrationPatients undergo ART over 60-90 minutes once a week for up to 5 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to read, write and understand English
- Undergone chemotherapy, radiation therapy, chimeric antigen receptor T cells (CAR-T), or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer
- A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time)
- A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
- Denial of suicidal ideation or intent, with no evidence of psychotic behavior
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PsychotherapyAlso: talk therapyUndergo ART | Behavioural | Supportive care (ART) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (ART) |
Primary outcome
Psychological trauma
Time frame: Up to 6 weeks
Symptoms of psychological trauma will be measured with both the Primary Care-Post Traumatic Stress Disorder Screening (PC-PTSD-5) and the Post Traumatic Stress Disorder Checklist (PCL-5). The PCL-5 (PTSD Patient Checklist) is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma). The total symptom severity score ranges from 0 to 80.
Cancer distress
Time frame: Up to 6 weeks
Cancer distress will be measured with the Cancer Treatment Distress Scale (CTxD). The CTxD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience.
4 secondary outcomes
Anxiety
Time frame: Up to 6 weeks
Depression
Time frame: Up to 6 weeks
Resilience
Time frame: Up to 6 weeks
Symptom distress
Time frame: Up to 6 weeks
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 27 Dec 2024.
- Derived from this study: PubMed 39902953Tofthagen C, Donovan KA, Mandrekar J, Buck HG. Accelerated Resolution Therapy for Cancer Distress and Post-Traumatic Stress Symptoms: Results of a Pilot Study. Psychooncology. 2025 Jan;34(1):e70058. doi: 10.1002/pon.70058.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Hematopoietic and Lymphoid System Neoplasm
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
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.
Cindy Tofthagen, Ph.D., R.N. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site 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 6 inclusion and 0 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 27 Dec 2024. 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 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.
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?
Psychological trauma (time frame: Up to 6 weeks). The study lists 2 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 NCT04436835, which also lists 1 linked publication.
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 Dec 2024.