AnxietyNCT02747160
Anxiety With Cancer in the Elderly (ACE): A Cognitive-behavioral Intervention
A study testing Managing Anxiety from Cancer (MAC) in people with Anxiety and Depression, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety, Depression, Quality of Life
- What is being tested?
- Managing Anxiety from Cancer (MAC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 2 Jul 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient age 65 years or older
- Diagnosis of cancer
- Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale
- A primary informal caregiver who is willing and able to participate
- Patient and caregiver are able to communicate over the telephone
- Caregiver is age 21 years or older.
Who cannot join
- Patient or caregiver is not fluent in English
- Patient or caregiver is too weak or cognitively impaired to participate in the intervention
- Patient or caregiver has received CBT since the patient's cancer diagnosis
- Patient or caregiver has an active major psychiatric condition such as schizophrenia
- Patient only experiences anxiety in the context of a specific medical procedure
- Patient or caregiver endorses active suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer
The purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).
Read the detailed description
This study is a single arm pre-post evaluation of a six-session telephone-administered cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and their primary informal (unpaid) caregiver. The primary purposes of this study are to evaluate the feasibility of the intervention and study procedures, acceptability of the intervention to older adults with cancer and their primary informal caregiver, and patient and caregiver adherence to the intervention. The secondary purpose is to examine changes in patient and caregiver anxiety, depression, distress, and quality of life pre to post intervention to determine whether the intervention has a clinically significant impact on these outcomes. Anxiety is the primary outcome; depression, distress, and quality of life are secondary outcomes. Patients will be 65 years of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, and gastrointestinal cancer clinics at a single institution. Study measures will be administered by telephone prior to initiating the intervention (pre-intervention) and following intervention completion (post-intervention).
- Conditions
- Anxiety, Depression, Quality of Life
- Being tested
- Managing Anxiety from Cancer (MAC)
- Keywords
- Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Anxiety from Cancer (MAC)Behavioural
The intervention consists of six telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques (patient only), problem-solving strategies (caregiver only), and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer.
| Study group | Role | What they receive |
|---|---|---|
| Managing Anxiety from Cancer (MAC) | Experimental | Older adults with cancer and their primary informal caregiver will receive a six-session cognitive-behavior therapy intervention administered over the telephone by a trained study interventionist. The intervention is administered weekly and each session is 45-50 minutes in length. Patients and caregivers will receive the intervention independently and from separate therapists. Receives: Behavioral: Managing Anxiety from Cancer (MAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility
Attrition rates
Measured: Post-intervention (6-8 weeks after baseline)
Intervention acceptability
Likert scale ratings of perceived helpfulness and readability of the intervention
Measured: Post-intervention (6-8 weeks after baseline)
Patient/caregiver adherence
Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers
Measured: Post-intervention (6-8 weeks after baseline)
Secondary outcomes (4)
Change in anxiety from baseline to post-intervention
Anxiety sub-scale of the Hospital Anxiety and Depression Scale
Measured: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Change in distress from baseline to post-intervention
Distress Thermometer
Measured: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Emotional health-related quality of life
Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale; Caregiver Quality of Life-Cancer
Measured: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Change in depression from baseline to post-intervention
Depression sub-scale of the Hospital Anxiety and Depression Scale
Measured: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Kelly M Trevino, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747160
- Sponsor's protocol ID
- 19-280
- Status last verified
- Oct 2020
- First submitted
- 12 Apr 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer
- ClinicalTrials.gov ID
- NCT02747160
- Acronym / sponsor ID
- 19-280
- Conditions
- Anxiety, Depression, Quality of Life
- Keywords
- Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Jun 2016 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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 purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).
Detailed description
This study is a single arm pre-post evaluation of a six-session telephone-administered cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and their primary informal (unpaid) caregiver. The primary purposes of this study are to evaluate the feasibility of the intervention and study procedures, acceptability of the intervention to older adults with cancer and their primary informal caregiver, and patient and caregiver adherence to the intervention. The secondary purpose is to examine changes in patient and caregiver anxiety, depression, distress, and quality of life pre to post intervention to determine whether the intervention has a clinically significant impact on these outcomes. Anxiety is the primary outcome; depression, distress, and quality of life are secondary outcomes. Patients will be 65 years of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, and gastrointestinal cancer clinics at a single institution. Study measures will be administered by telephone prior to initiating the intervention (pre-intervention) and following intervention completion (post-intervention).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Managing Anxiety from Cancer (MAC) | Experimental | Behavioral: Managing Anxiety from Cancer (MAC)Older adults with cancer and their primary informal caregiver will receive a six-session cognitive-behavior therapy intervention administered over the telephone by a trained study interventionist. The intervention is administered weekly and each session is 45-50 minutes in length. Patients and caregivers will receive the intervention independently and from separate therapists. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patient age 65 years or older
- Diagnosis of cancer
- Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale
- A primary informal caregiver who is willing and able to participate
- Patient and caregiver are able to communicate over the telephone
Key exclusion criteria (6 listed)
- Patient or caregiver is not fluent in English
- Patient or caregiver is too weak or cognitively impaired to participate in the intervention
- Patient or caregiver has received CBT since the patient's cancer diagnosis
- Patient or caregiver has an active major psychiatric condition such as schizophrenia
- Patient only experiences anxiety in the context of a specific medical procedure
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 |
|---|---|---|
| Managing Anxiety from Cancer (MAC)The intervention consists of six telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques (patient only), problem-solving strategies (caregiver only), and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer. | Behavioural | Managing Anxiety from Cancer (MAC) |
Primary outcome
Intervention feasibility
Time frame: Post-intervention (6-8 weeks after baseline)
Attrition rates
Intervention acceptability
Time frame: Post-intervention (6-8 weeks after baseline)
Likert scale ratings of perceived helpfulness and readability of the intervention
Patient/caregiver adherence
Time frame: Post-intervention (6-8 weeks after baseline)
Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers
4 secondary outcomes
Change in anxiety from baseline to post-intervention
Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Change in distress from baseline to post-intervention
Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Emotional health-related quality of life
Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Change in depression from baseline to post-intervention
Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
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 14 Oct 2020.
- 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. This study is not recruiting at the moment.
Kelly M Trevino, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Anxiety from Cancer (MAC) in people with Anxiety and Depression, run by Memorial Sloan Kettering Cancer Center 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 6 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 14 Oct 2020. 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?
Intervention feasibility (time frame: Post-intervention (6-8 weeks after baseline)). 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?
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 14 Oct 2020.