SurvivorshipNCT04611620
Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms
An observational study of Survivorship and Cognitive Dysfunction, run by Indiana University at 1 site in United States.
Trial summary
This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Survivorship, Cognitive Dysfunction, Pain
- What is being tested?
- Cognitive Dysfunction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 682 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 27 Jul 2021
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 465 breast and colorectal cancer patients will be recruited for this study. Breast and colorectal cancer survivors. The eligibility checklist is a self-report questionnaire. Participants will be asked to self-identify that they are 21 years of age or older, had been diagnosed with breast or colorectal cancer excluding Stage IV (those without distant metastasis) and have completed treatment (adjuvant or neo-adjuvant) at least 6 months prior to completing the survey. In addition, as part of the eligibility checklist, participants will need to self-rate that they have cognitive concerns (select yes).
Who may be able to join
- Female BCS
- ≥ 21 years of age and older
- Ability to provide written consent and HIPAA authorization
- ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (Stage I-IIIA) breast cancer.
- Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.
- Identify cognitive concerns (select yes)
Show all 11Show fewer
- Male or female CRC survivors
- Ability to provide written consent and HIPAA authorization
- ≥ 21 years of age and older
- ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III) CRC
- Identify cognitive concerns (select yes)
Who cannot join
- Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.
- Unable to read and understand English to complete survey questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.
Read the detailed description
Primary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (APOE, COMT, BDNF) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors.
Secondary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (APOE, COMT, BDNF) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.
- Conditions
- Survivorship, Cognitive Dysfunction, Pain, Depression, Anxiety, Fatigue
- Being tested
- Cognitive Dysfunction
- Keywords
- Breast Cancer and Colorectal Cancer, Co-Occurring Symptoms
- Medical subject headings
- Cognitive Dysfunction, Pain, Depression, Anxiety Disorders, Fatigue, Parasomnias, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive DysfunctionBehavioural
To fully characterize factors associated with cognitive dysfunction in BCS and CRC survivors that have cognitive concerns and (2) to fully characterize factors associated with psychoneurological symptom cluster in BCS and CRC survivors.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer and Colorectal Cancer Survivors | The purpose of this study is to explore the factors related with cognitive concerns and other symptoms in breast and colorectal cancer survivors. Receives: Behavioral: Cognitive Dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cognitive Dysfunction
PROMIS - Cognitive Abilities and Concerns
Measured: greater than or equal to 6 months post cancer treatment
Secondary outcomes (5)
Objective Cognitive Dysfunction
Visual Episodic Memory
Measured: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Working Memory
Measured: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Executive Functioning
Measured: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Sustained Attention
Measured: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Visuospatial Working Memory
Measured: greater than or equal to 6 months post cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start16 Nov 2020
- Primary completion12 May 2021
- Study completion27 Jul 2021
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 SurvivorshipStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane Von Ah, Indiana University
- Investigators
- Diane Von Ah, PhD, Principal investigator, IU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611620
- Sponsor's protocol ID
- NURS-IIR-IUSCCC-0748
- Status last verified
- Feb 2023
- First submitted
- 12 Oct 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goto T, Saligan LN, Li X, Xiang L, Kwiat C, Nguyen C, Crouch A, Von Ah D. Associations of brain-derived neurotrophic factor rs6265 polymorphism and cognitive function in breast cancer survivors from a cross-sectional study. Cancer Med. 2024 Jan;13(2):e6975. doi: 10.1002/cam4.6975.
PubMed 38379321Storey S, Draucker C, Haunert L, Von Ah D. The Experience of Peripheral Neuropathy Symptoms in Breast Cancer Survivors With Diabetes. Cancer Nurs. 2024 Jul-Aug 01;47(4):E279-E286. doi: 10.1097/NCC.0000000000001253. Epub 2023 May 26.
PubMed 37232534
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms
- ClinicalTrials.gov ID
- NCT04611620
- Acronym / sponsor ID
- NURS-IIR-IUSCCC-0748
- Conditions
- Survivorship, Cognitive Dysfunction, Pain, Depression, Anxiety, Fatigue
- Keywords
- Breast Cancer and Colorectal Cancer, Co-Occurring Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 2 Nov 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 descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.
Detailed description
Primary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (APOE, COMT, BDNF) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors.
Secondary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (APOE, COMT, BDNF) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer and Colorectal Cancer Survivors | – | Behavioral: Cognitive DysfunctionThe purpose of this study is to explore the factors related with cognitive concerns and other symptoms in breast and colorectal cancer survivors. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 465 breast and colorectal cancer patients will be recruited for this study. Breast and colorectal cancer survivors. The eligibility checklist is a self-report questionnaire. Participants will be asked to self-identify that they are 21 years of age or older, had been diagnosed with breast or colorectal cancer excluding Stage IV (those without distant metastasis) and have completed treatment (adjuvant or neo-adjuvant) at least 6 months prior to completing the survey. In addition, as part of the eligibility checklist, participants will need to self-rate that they have cognitive concerns (select yes).
Key inclusion criteria (11 listed)
- Female BCS
- ≥ 21 years of age and older
- Ability to provide written consent and HIPAA authorization
- ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (Stage I-IIIA) breast cancer.
- Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.
Key exclusion criteria (2 listed)
- Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.
- Unable to read and understand English to complete survey questionnaires.
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 |
|---|---|---|
| Cognitive DysfunctionTo fully characterize factors associated with cognitive dysfunction in BCS and CRC survivors that have cognitive concerns and (2) to fully characterize factors associated with psychoneurological symptom cluster in BCS and CRC survivors. | Behavioural | Breast Cancer and Colorectal Cancer Survivors |
Primary outcome
Subjective Cognitive Dysfunction
Time frame: greater than or equal to 6 months post cancer treatment
PROMIS - Cognitive Abilities and Concerns
5 secondary outcomes
Objective Cognitive Dysfunction
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time frame: greater than or equal to 6 months post cancer 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 22 Feb 2023.
- Derived from this study: PubMed 38379321Goto T, Saligan LN, Li X, Xiang L, Kwiat C, Nguyen C, Crouch A, Von Ah D. Associations of brain-derived neurotrophic factor rs6265 polymorphism and cognitive function in breast cancer survivors from a cross-sectional study. Cancer Med. 2024 Jan;13(2):e6975. doi: 10.1002/cam4.6975.
- Derived from this study: PubMed 37232534Storey S, Draucker C, Haunert L, Von Ah D. The Experience of Peripheral Neuropathy Symptoms in Breast Cancer Survivors With Diabetes. Cancer Nurs. 2024 Jul-Aug 01;47(4):E279-E286. doi: 10.1097/NCC.0000000000001253. Epub 2023 May 26.
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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.
Diane Von Ah, PhD principal investigator
IU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivorship and Cognitive Dysfunction, run by Indiana University 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 11 inclusion and 2 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 22 Feb 2023. 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?
Subjective Cognitive Dysfunction (time frame: greater than or equal to 6 months post cancer treatment). 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 NCT04611620, 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 22 Feb 2023.