Breast CancerNCT05830461
Online Psychological Care Program for Women Who Attend a Breast Clinic.
A study testing Online psychological care program to reduce psychological distress in women who attend a breast clinic and Psychological care program to reduce psychological distress in women who attend a breast clinic in people with Breast Cancer, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The objective of this study is to evaluate the effectiveness of an online psychological care program to reduce anxiety, depression and negative psychological consequences and to increase a sense of coherence in the process of diagnostic evaluation and/or screening of mammary glands in women who attend a breast clinic. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Online psychological care program to reduce psychological distress in women who attend a breast clinic and Psychological care program to reduce psychological distress in women who attend a breast clinic
- 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 siteMexico
- Study dates
- 19 Oct 2023to Aug 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of legal age who attend a health institution for screening studies and/or diagnostic evaluation of breast cancer.
- Patients who can use an electronic device (smart phone, computer, laptop, tablet) to access the virtual platform.
- Patients who give their informed consent to participate in the study.
Who cannot join
- Patients with suicidal ideation and/or attempt.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social
Guadalajara, Jalisco, 44300
Sergio O Meza Chavolla, MD, +52 1 33 3168 8948, sergio.mezac@imss.gob.mx
About this study
Official title: Online Psychological Care Program to Reduce Psychological Distress in the Process of Diagnostic Evaluation and/or Screening of Mammary Glands in Women Who Attend a Breast Clinic.
The objective of this study is to evaluate the effectiveness of an online psychological care program to reduce anxiety, depression and negative psychological consequences and to increase a sense of coherence in the process of diagnostic evaluation and/or screening of mammary glands in women who attend a breast clinic.
There will be an experimental group and a control group. The experimental group will receive the psychological intervention through a virtual platform and the control group will be given visual material with the information. This platform will be designed based on the principles of user experience (UX).
Read the detailed description
It has been shown that women who undergo diagnostic tests or screening of their mammary glands present symptoms associated with anxiety, concerns regarding a possible positive result for malignancy, as well as emotional distress. It is important to generate psychological programs aimed at reducing the psychological consequences of the diagnostic evaluation and/or screening of mammary glands because there are few approaches on the subject.
In Mexico there are breast clinics of the Mexican Social Security Institute, designed to perform screening tests and diagnostic evaluation of mammary glands, with the aim of identifying cases of breast cancer in early stages. However, few psychological interventions have been reported during the diagnostic process, so it is important to know the psychological affectations presented by women who undergo these tests. Given this, this intervention has the objective of evaluating the effectiveness of an online psychological care program to reduce psychological distress and increase the sense of coherence in the process of diagnostic evaluation of mammary glands in women who attend a breast clinic.
In the intervention there will be two groups: a) experimental group and b) control group.
The experimental group will receive online psychological care through the virtual platform and the patients in the control group will be given visual material with the information.
All participants will be invited to attend the breast clinic and undergo screening studies and/or diagnostic evaluation. For the assignment of the experimental and control group, it will be carried out through a randomization process through the Excel program.
- Conditions
- Breast Cancer
- Being tested
- Online psychological care program to reduce psychological distress in women who attend a breast clinic, Psychological care program to reduce psychological distress in women who attend a breast clinic
- Keywords
- Cancer Screening Tests, Anxiety, Depression, Sense of coherence, Psychological Intervention, Internet-Based Intervention
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online psychological care program to reduce psychological distress in women who attend a breast clinicBehavioural
The intervention will be online and self-applied. It will consist of 3 stages, according to the patient's situation: 1) without suspicion of cancer (A1), 2) with suspicion of cancer (A2), and 3) with confirmed diagnosis of cancer (B).
Stage 1 includes modules related to the prevention and timely detection of breast cancer. Stage A2 consists of emotional management in the face of suspicion of breast cancer. In stage B, medical information about breast cancer is provided, as well as psychological strategies to face the diagnosis.
Psychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included.
Psychological care program to reduce psychological distress in women who attend a breast clinicBehavioural
The intervention will be delivered through printed materials. It will consist of 3 stages, according to the patient's situation: 1) without suspicion of cancer (A1), 2) with suspicion of cancer (A2), and 3) with confirmed diagnosis of cancer (B).
Stage 1 includes modules related to the prevention and timely detection of breast cancer. Stage A2 consists of emotional management in the face of suspicion of breast cancer. In stage B, medical information about breast cancer is provided, as well as psychological strategies to face the diagnosis.
Psychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive the self-applied intervention through a digital platform. The intervention consists of three stages, depending on the situation of the patient: 1) Patients who undergo screening and obtain negative results for malignancy, 2) patients with suspicion and undergo a biopsy, 3) Patients with positive results for breast cancer. Receives: Behavioral: Online psychological care program to reduce psychological distress in women who attend a breast clinic |
| Control group | Active comparator | The experimental group will receive the self-applied intervention through written visual material that will be given to them. The content of the material will be the same as the experimental group. Receives: Behavioral: Psychological care program to reduce psychological distress in women who attend a breast clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the scores of the Hospital Anxiety and Depression Scale
This is an instrument that comprises 14 items: seven to measure anxiety and seven to measure depression experienced in the previous week. The Hospital Anxiety and Depression Scale was validated in Mexican population with a reliability of 0.81 for anxiety and 0.82 for depression. Anxiety items evaluate whether the person has been worried or has experienced sensations of fear, while depression items evaluate anhedonia or pessimistic thoughts.
Measured: 1 month, depends on when the participant finishes the modules.
Change in the scores of the Psychological Consequences Questionnaire
Evaluates the negative psychological consequences of breast cancer screening. It contemplates three dimensions: Emotional Affects, Physical Affects and Social Affects.
Measured: 1 month, depends on when the participant finishes the modules.
Secondary outcomes (1)
Change in the scores of the Sense of coherence
Evaluates coping with stressors in the illness-well-being continuum and possible solutions to the conflict. It contemplates three dimensions: understandability, manageability and significance. Reliability tests showed a Cronbach´s alpha of .80 overall scale in latin populations.
Measured: 1 month, depends on when the participant finishes the modules.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start19 Oct 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- The study has two arms, one is the experimental group that will receive the treatment through the online platform only, and the other is the comparison group that will receive the treatment delivered through printed visual material. The program consists of three stages that are aimed at: 1) Patients who undergo screening and obtain negative results for malignancy, 2) patients with suspicion and undergo a biopsy, 3) Patients with positive results for breast cancer.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social, Tecnologico de Monterrey, Universidad Internacional del Ecuador, University of Twente
- Responsible party
- Principal investigator, Reyna Jazmin Martinez Arriaga, University of Guadalajara
- Investigators
- Reyna J Martínez Arriaga, PhD, Principal investigator, University of GuadalajaraAlejandro Domínguez Rodríguez, PhD, Study chair, University of TwenteSergio O Meza Chavolla, MD, Study chair, Instituto Mexicano del Seguro SocialFabiola Macías Espinoza, PhD, Study chair, University of GuadalajaraJoel O González Cantero, PhD, Study chair, University of GuadalajaraLeivy P González Ramírez, PhD, Study chair, Tecnologico de MonterreyPaulina Herdoiza Arroyo, PhD, Study chair, Universidad Internacional del EcuadorYineth A Muñoz Anacona, BD, Study chair, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830461
- Sponsor's protocol ID
- CI-01022
- Status last verified
- Jun 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants will be recruited in a public health institution. Since it is a government institution, one of the rules regarding the information collected is that it cannot be shared with other people or institutions outside the institution.
Publications
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Cockburn J, De Luise T, Hurley S, Clover K. Development and validation of the PCQ: a questionnaire to measure the psychological consequences of screening mammography. Soc Sci Med. 1992 May;34(10):1129-34. doi: 10.1016/0277-9536(92)90286-y.
PubMed 1641674Antonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993 Mar;36(6):725-33. doi: 10.1016/0277-9536(93)90033-z.
PubMed 8480217Brandon CJ, Mullan PB. Patients' perception of care during image-guided breast biopsy in a rural community breast center: communication matters. J Cancer Educ. 2011 Mar;26(1):156-60. doi: 10.1007/s13187-010-0178-7.
PubMed 21188664Castaneda SF, Malcarne VL, Foster-Fishman PG, Davidson WS, Mumman MK, Riley N, Sadler GR. Health care access and breast cancer screening among Latinas along the California-Mexican border. J Immigr Minor Health. 2014 Aug;16(4):670-81. doi: 10.1007/s10903-013-9938-x.
PubMed 24150421Chujo M, Kigawa J, Okamura H. Psychological Factors and Characteristics of Recurrent Breast Cancer Patients with or without Psychosocial Group Therapy Intervention. Yonago Acta Med. 2011 Dec;54(4):65-74. Epub 2011 Dec 1.
PubMed 24031131Consedine NS, Magai C, Krivoshekova YS, Ryzewicz L, Neugut AI. Fear, anxiety, worry, and breast cancer screening behavior: a critical review. Cancer Epidemiol Biomarkers Prev. 2004 Apr;13(4):501-10.
PubMed 15066912Dominguez-Rodriguez A, Martinez-Luna SC, Hernandez Jimenez MJ, De La Rosa-Gomez A, Arenas-Landgrave P, Esquivel Santovena EE, Arzola-Sanchez C, Alvarez Silva J, Solis Nicolas AM, Colmenero Guadian AM, Ramirez-Martinez FR, Vargas ROC. A Self-Applied Multi-Component Psychological Online Intervention Based on UX, for the Prevention of Complicated Grief Disorder in the Mexican Population During the COVID-19 Outbreak: Protocol of a Randomized Clinical Trial. Front Psychol. 2021 Mar 29;12:644782. doi: 10.3389/fpsyg.2021.644782. eCollection 2021.
PubMed 33854466Fang SY, Wang YL, Lu WH, Lee KT, Kuo YL, Fetzer SJ. Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. Patient Educ Couns. 2020 Mar;103(3):549-555. doi: 10.1016/j.pec.2019.09.012. Epub 2019 Sep 12.
PubMed 31558323Galiano-Castillo N, Cantarero-Villanueva I, Fernandez-Lao C, Ariza-Garcia A, Diaz-Rodriguez L, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors. Cancer. 2016 Oct 15;122(20):3166-3174. doi: 10.1002/cncr.30172. Epub 2016 Jun 22.
PubMed 27332968Hollis C, Morriss R, Martin J, Amani S, Cotton R, Denis M, Lewis S. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry. 2015 Apr;206(4):263-5. doi: 10.1192/bjp.bp.113.142612.
PubMed 25833865Holtdirk F, Mehnert A, Weiss M, Meyer B, Watzl C. Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. Trials. 2020 Jan 29;21(1):117. doi: 10.1186/s13063-019-3987-y.
PubMed 31996235Liao MN, Chen MF, Chen SC, Chen PL. Uncertainty and anxiety during the diagnostic period for women with suspected breast cancer. Cancer Nurs. 2008 Jul-Aug;31(4):274-83. doi: 10.1097/01.NCC.0000305744.64452.fe.
PubMed 18600114Montgomery M, McCrone SH. Psychological distress associated with the diagnostic phase for suspected breast cancer: systematic review. J Adv Nurs. 2010 Nov;66(11):2372-90. doi: 10.1111/j.1365-2648.2010.05439.x.
PubMed 21039773Martinez-Arriaga RJ, Dominguez-Rodriguez A, Meza-Chavolla SO, Munoz-Anacona YA, Cisneros-Hernandez AA, Gonzalez-Cantero JO, Gonzalez-Ramirez LP, Herdoiza-Arroyo PE, Ruvalcaba-Romero NA, Macias-Espinoza F, Jimenez S. "Salud Mamaria", an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2024 Nov 26;43:101397. doi: 10.1016/j.conctc.2024.101397. eCollection 2025 Feb.
PubMed 39802661
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Psychological Care Program to Reduce Psychological Distress in the Process of Diagnostic Evaluation and/or Screening of Mammary Glands in Women Who Attend a Breast Clinic.
- ClinicalTrials.gov ID
- NCT05830461
- Acronym / sponsor ID
- CI-01022
- Conditions
- Breast Cancer
- Keywords
- Cancer Screening Tests, Anxiety, Depression, Sense of coherence, Psychological Intervention, Internet-Based Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social, Tecnologico de Monterrey, Universidad Internacional del Ecuador, University of Twente
- Study start
- 19 Oct 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Apr 2023 (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 objective of this study is to evaluate the effectiveness of an online psychological care program to reduce anxiety, depression and negative psychological consequences and to increase a sense of coherence in the process of diagnostic evaluation and/or screening of mammary glands in women who attend a breast clinic.
There will be an experimental group and a control group. The experimental group will receive the psychological intervention through a virtual platform and the control group will be given visual material with the information. This platform will be designed based on the principles of user experience (UX).
Detailed description
It has been shown that women who undergo diagnostic tests or screening of their mammary glands present symptoms associated with anxiety, concerns regarding a possible positive result for malignancy, as well as emotional distress. It is important to generate psychological programs aimed at reducing the psychological consequences of the diagnostic evaluation and/or screening of mammary glands because there are few approaches on the subject.
In Mexico there are breast clinics of the Mexican Social Security Institute, designed to perform screening tests and diagnostic evaluation of mammary glands, with the aim of identifying cases of breast cancer in early stages. However, few psychological interventions have been reported during the diagnostic process, so it is important to know the psychological affectations presented by women who undergo these tests. Given this, this intervention has the objective of evaluating the effectiveness of an online psychological care program to reduce psychological distress and increase the sense of coherence in the process of diagnostic evaluation of mammary glands in women who attend a breast clinic.
In the intervention there will be two groups: a) experimental group and b) control group.
The experimental group will receive online psychological care through the virtual platform and the patients in the control group will be given visual material with the information.
All participants will be invited to attend the breast clinic and undergo screening studies and/or diagnostic evaluation. For the assignment of the experimental and control group, it will be carried out through a randomization process through the Excel program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study has two arms, one is the experimental group that will receive the treatment through the online platform only, and the other is the comparison group that will receive the treatment delivered through printed visual material. The program consists of three stages that are aimed at: 1) Patients who undergo screening and obtain negative results for malignancy, 2) patients with suspicion and undergo a biopsy, 3) Patients with positive results for breast cancer.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Online psychological care program to reduce psychological distress in women who attend a breast clinicThe experimental group will receive the self-applied intervention through a digital platform. The intervention consists of three stages, depending on the situation of the patient: 1) Patients who undergo screening and obtain negative results for malignancy, 2) patients with suspicion and undergo a biopsy, 3) Patients with positive results for breast cancer. |
| Control group | Active comparator | Behavioral: Psychological care program to reduce psychological distress in women who attend a breast clinicThe experimental group will receive the self-applied intervention through written visual material that will be given to them. The content of the material will be the same as the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of legal age who attend a health institution for screening studies and/or diagnostic evaluation of breast cancer.
- Patients who can use an electronic device (smart phone, computer, laptop, tablet) to access the virtual platform.
- Patients who give their informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients with suicidal ideation and/or attempt.
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 |
|---|---|---|
| Online psychological care program to reduce psychological distress in women who attend a breast clinicThe intervention will be online and self-applied. It will consist of 3 stages, according to the patient's situation: 1) without suspicion of cancer (A1), 2) with suspicion of cancer (A2), and 3) with confirmed diagnosis of cancer (B). Stage 1 includes modules related to the prevention and timely detection of breast cancer. Stage A2 consists of emotional management in the face of suspicion of breast cancer. In stage B, medical information about breast cancer is provided, as well as psychological strategies to face the diagnosis. Psychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included. | Behavioural | Experimental group |
| Psychological care program to reduce psychological distress in women who attend a breast clinicThe intervention will be delivered through printed materials. It will consist of 3 stages, according to the patient's situation: 1) without suspicion of cancer (A1), 2) with suspicion of cancer (A2), and 3) with confirmed diagnosis of cancer (B). Stage 1 includes modules related to the prevention and timely detection of breast cancer. Stage A2 consists of emotional management in the face of suspicion of breast cancer. In stage B, medical information about breast cancer is provided, as well as psychological strategies to face the diagnosis. Psychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included. | Behavioural | Control group |
Primary outcome
Change in the scores of the Hospital Anxiety and Depression Scale
Time frame: 1 month, depends on when the participant finishes the modules.
This is an instrument that comprises 14 items: seven to measure anxiety and seven to measure depression experienced in the previous week. The Hospital Anxiety and Depression Scale was validated in Mexican population with a reliability of 0.81 for anxiety and 0.82 for depression. Anxiety items evaluate whether the person has been worried or has experienced sensations of fear, while depression items evaluate anhedonia or pessimistic thoughts.
Change in the scores of the Psychological Consequences Questionnaire
Time frame: 1 month, depends on when the participant finishes the modules.
Evaluates the negative psychological consequences of breast cancer screening. It contemplates three dimensions: Emotional Affects, Physical Affects and Social Affects.
1 secondary outcome
Change in the scores of the Sense of coherence
Time frame: 1 month, depends on when the participant finishes the modules.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 1641674Cockburn J, De Luise T, Hurley S, Clover K. Development and validation of the PCQ: a questionnaire to measure the psychological consequences of screening mammography. Soc Sci Med. 1992 May;34(10):1129-34. doi: 10.1016/0277-9536(92)90286-y.
- Background: PubMed 8480217Antonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993 Mar;36(6):725-33. doi: 10.1016/0277-9536(93)90033-z.
- Background: PubMed 21188664Brandon CJ, Mullan PB. Patients' perception of care during image-guided breast biopsy in a rural community breast center: communication matters. J Cancer Educ. 2011 Mar;26(1):156-60. doi: 10.1007/s13187-010-0178-7.
- Background: PubMed 24150421Castaneda SF, Malcarne VL, Foster-Fishman PG, Davidson WS, Mumman MK, Riley N, Sadler GR. Health care access and breast cancer screening among Latinas along the California-Mexican border. J Immigr Minor Health. 2014 Aug;16(4):670-81. doi: 10.1007/s10903-013-9938-x.
- Background: PubMed 24031131Chujo M, Kigawa J, Okamura H. Psychological Factors and Characteristics of Recurrent Breast Cancer Patients with or without Psychosocial Group Therapy Intervention. Yonago Acta Med. 2011 Dec;54(4):65-74. Epub 2011 Dec 1.
- Background: PubMed 15066912Consedine NS, Magai C, Krivoshekova YS, Ryzewicz L, Neugut AI. Fear, anxiety, worry, and breast cancer screening behavior: a critical review. Cancer Epidemiol Biomarkers Prev. 2004 Apr;13(4):501-10.
- Background: PubMed 33854466Dominguez-Rodriguez A, Martinez-Luna SC, Hernandez Jimenez MJ, De La Rosa-Gomez A, Arenas-Landgrave P, Esquivel Santovena EE, Arzola-Sanchez C, Alvarez Silva J, Solis Nicolas AM, Colmenero Guadian AM, Ramirez-Martinez FR, Vargas ROC. A Self-Applied Multi-Component Psychological Online Intervention Based on UX, for the Prevention of Complicated Grief Disorder in the Mexican Population During the COVID-19 Outbreak: Protocol of a Randomized Clinical Trial. Front Psychol. 2021 Mar 29;12:644782. doi: 10.3389/fpsyg.2021.644782. eCollection 2021.
- Background: PubMed 31558323Fang SY, Wang YL, Lu WH, Lee KT, Kuo YL, Fetzer SJ. Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. Patient Educ Couns. 2020 Mar;103(3):549-555. doi: 10.1016/j.pec.2019.09.012. Epub 2019 Sep 12.
- Background: PubMed 27332968Galiano-Castillo N, Cantarero-Villanueva I, Fernandez-Lao C, Ariza-Garcia A, Diaz-Rodriguez L, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors. Cancer. 2016 Oct 15;122(20):3166-3174. doi: 10.1002/cncr.30172. Epub 2016 Jun 22.
- Background: PubMed 25833865Hollis C, Morriss R, Martin J, Amani S, Cotton R, Denis M, Lewis S. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry. 2015 Apr;206(4):263-5. doi: 10.1192/bjp.bp.113.142612.
- Background: PubMed 31996235Holtdirk F, Mehnert A, Weiss M, Meyer B, Watzl C. Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. Trials. 2020 Jan 29;21(1):117. doi: 10.1186/s13063-019-3987-y.
- Information about breast cancer screeningLink provided by the sponsor.
- Individual participant dataSharing planned: No. The participants will be recruited in a public health institution. Since it is a government institution, one of the rules regarding the information collected is that it cannot be shared with other people or institutions outside the institution.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Reyna J Martínez Arriaga, PhD principal investigator
University of Guadalajara
Alejandro Domínguez Rodríguez, PhD study chair
University of Twente
Sergio O Meza Chavolla, MD study chair
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online psychological care program to reduce psychological distress in women who attend a breast clinic and Psychological care program to reduce psychological distress in women who attend a breast clinic in people with Breast Cancer, run by University of Guadalajara at 1 site in Mexico.
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 3 inclusion and 1 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 3 Jul 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reyna J Martínez Arriaga, PhD (+52 1 3311979082, reyna.martinez@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the scores of the Hospital Anxiety and Depression Scale (time frame: 1 month, depends on when the participant finishes the modules.). 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 NCT05830461, which also lists 15 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 3 Jul 2023.