Uterine Cervical NeoplasmsSUCCEEDERNCT06124040
Sexual Function, Coping and Dyadic Coping in Patients With Cervical Cancer
An observational study of Uterine Cervical Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- psychological assessment evaluation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2023to 31 Oct 2024
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical cancer neo diagnosis, pertaining to the Gynecologic Oncology and Radiotherapy Oncology Units of Fondazione Policlinico Universitario A. Gemelli IRCCS, candidates for surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines. Based on the evidence in literature and the historical of our Institution (throughout the year 2022: 81 radiotherapy plus chemotherapy, 64 surgery), assuming a slightly lower mean difference in psychological tests scores between the two groups due to the recent improvement in irradiation techniques since the previous publication, we calculated the final sample size is 154 patients, 88 undergoing radiotherapy plus chemotherapy and 66 undergoing surgery.
Who may be able to join
- Patients' age ≥ 18 years
- Patients undergoing non-conservative surgery or radiotherapy plus chemotherapy
- Patients able to understand and sign informed consent
Who cannot join
- Patients' age > 65 years
- Patients with inability to express informed consent
- Patients denying informed consent
- Patients with psychopathological disturbances preexisting to the cancer diagnosis
- Patients affected by severe language deficits
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, RM, 00168
Letizia Lafuenti, 00390630156280, letizia.lafuenti1@policlinicogemelli.it
About this study
Official title: Sexual Function, Coping and Dyadic Coping in Cervical Cancer Patients: a Comparison Between Surgery and Radiotherapy Plus Chemotherapy
The studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. Moreover, a baseline evaluation about sexual function and coping if often lacking.
Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:
Read more
- To assess sexual function, coping, emotional distress, and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy.
- To evaluate changes on the previous variables over 6 months.
The results obtained will be utilized for:
- planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis
- develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients.
Read the detailed description
Many recent reviews focused on QoL and the sexual function of patients with cervical cancer and have only evaluated the sexual dysfunctions of patients undergoing chemo-radiotherapy plus interventional radiotherapy.
The studies currently available in the literature are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. In fact, psychological factors caused by the cancer diagnosismay also negatively influence sexual functioning independently of the type of treatment or stage of cancer.
Common psychological issues included poor body image, decreased sense of femininity, anxiety about sexual interactions, and pain.
Consequently, related social issues may emerge, for example, the ability to maintain a sexual relationship, communication difficulties, and adverse effects on intimate relationships.
Women with cervical cancer have thus independently significant issues related to sexual functioning as a result of their disease and/or its treatment. The most important classification for cervical cancer is FIGO (International Federation Gynecology and Obstetrics) updated in 2021. Treatments for cervical cancer are different depending on this classification. Although early-stage cervical cancers have different prognosis and treatments with respect to invasive cervical cancers (surgery vs chemoradiation plus interventional radiotherapy), both types can have a major impact on patients' sexual function and coping, also dyadic coping since diagnosis.
For this reason, we decided to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:
Primary objectives: to assess sexual function and coping Secondary objective: to evaluate emotional distress; dyadic coping; anxiety and depression; QoL of patients with cervical cancer; association between coping and possible dissociative symptoms; changes on the previous variables over 6 months.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- psychological assessment evaluation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological assessment evaluationBehavioural
A prospective data collection will be performed with self-administered psychological measures, with the aim to compare two different groups of patients with cervical cancer neo diagnosis, candidates for non conservative surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines.
Test will be repeated at Time 0 (firs access in radiotherapy Day Hospital, or first access in hospital ward for surgery), and Time 1 (after 6 months).
| Study group | Role | What they receive |
|---|---|---|
| Radio-chemotherapy | Cervical cancer patients undergoing radio-chemotherapy. Receives: Behavioral: psychological assessment evaluation | |
| Surgery | Cervical cancer patients undergoing surgery. Receives: Behavioral: psychological assessment evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess sexual function in cervical cancer patients
Primary outcome is to assess sexual function of cervical cancer patients undergoing surgery vs patients undergoing radiotherapy plus chemotherapy.
This dimension will be assessed by "Female Sexual Function Index" (FSFI), a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The index only measures sexual function in these domains over the previous 30 days.
The FSFI can be used as a screening tool and as a potential diagnostic aid. A total cut-off score ≤ 26.55 has been proposed for the diagnosis of female sexual dysfunction, so any woman scoring below 26.55 should be considered at risk for sexual dysfunction.
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Assess individual coping strategies in cervical cancer patients
Assessment of individual coping strategies will be done in both groups by The Mini-Mental Adjustment to Cancer (Mini-MAC), a 29-item instrument that evaluates cognitive and behavioral responses to cancer. The factors of the Mini-MAC are: Fighting Spirit, Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Each item is rated on a 4-point scale that ranges from "definitely does not apply to me" to "definitely applies to me".
Each statement is rated on a scale from 1 (definitely not) to 4 (definitely yes), and the available scores for each of the four coping strategies range from 7 to 28 points.
The higher the score, the greater the coping/behavior style in the patient's fight against cancer.
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Secondary outcomes (5)
Evaluate dyadic coping in cervical cancer patients
Dyadic Adjustment Scale (DAS) will be adopted to assess the quality of romantic relationships in both patient and her partner, if any.
This tool evaluates the adaptability, quality, and representation that each partner has with regard to an intimate relationship. It is a self-reporting questionnaire consisting of 32 items, divided into four subscales: dyadic satisfaction, dyadic cohesive, dyadic and affective consent.
For this test there is not a real clinical cut-off, the higher the score the greater the cohesion within the couple. Minimum and maximum scores depend on the subscales:
- Suscale CONSENT ON IMPORTANT ISSUES: minimum score 0, maximum 4
- Subscale SATISFACTION WITH THE STATUS OF THE RELATIONSHIP: minimum score 0, maximum 5
- Subscale DOING TOGETHER: minimum score 0, maximum 4
- Subscale SATISFACTION FOR AFFECTIVE AND SEXUAL LIFE: minimum score 0, maximum 5
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate emotional Distress in cervical cancer patients
Both groups will be administred by Distress Thermometer (DT), to evaluate emotional distress.
Clinical cut-off are considered as follow:
DT: > or = 4 (scoring equal or higher than 4 means high emotional distress).
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate Anxiety and Depression in cervical cancer patients
Both groups will be administred by Hospital Anxiety and Depression Scale (HADS), to evaluate anxiety and depression.
Clinical cut-off are considered as follow:
HADS: 8-10 (a score lower than 8 means physiological levels of anxiety and depression; scores between 8 and 10 means the presence of anxiety and depression; scoring higher than 10 means high levels of anxiety and depression).
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate the presence of any dissociative symtoms in cervical cancer patients
The Dissociative Experience Scale (DES-II) measures a wide variety of dissociation types, including both problematic experiences and normal experiences (e.g., daydreaming). It is a screening tool for dissociative disorders, especially dissociative identity disorder and dissociative disorder not otherwise specified.
It is a 28-item questionnaire answered on a percentage scale ranging from 0% to 100%.
The total score can be between 0 and 100, and is obtained by dividing the global result by the number of items.
Scores higher than 30 indicate high levels of dissociation and are frequently reported in psychiatric patients with dissociative symptoms, while scores higher than 40 are related to post-traumatic stress disorder.
Dissociation occupies an important position in the genesis of emotional manifestations in patients affected by cancer.
In cancer, dissociative or post-traumatic symptoms can be related to coping strategies of anxious preoccupation and cognitive avoidance.
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate quality of life dimensions in cervical cancer patients
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Module (EORTC QLQ - CX24) is a Quality of Life questionnaire, designed to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer.
The QLQ-CX24 consists of 3 multi-item scales and 5 single-item scales which analyzed 3 dimensions: Symptom Experience; Body Image; Sexual/Vaginal Functioning.
All subscales have a minimum score of 0 (no symptoms) and a maximum score of 4 (high presence of symptoms). In general, high scores indicate dysfunctional or pathological characteristics.
Measured: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start23 Nov 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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-control
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124040
- Sponsor's protocol ID
- 6044
- Acronym
- SUCCEEDER
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function, Coping and Dyadic Coping in Cervical Cancer Patients: a Comparison Between Surgery and Radiotherapy Plus Chemotherapy
- ClinicalTrials.gov ID
- NCT06124040
- Acronym / sponsor ID
- SUCCEEDER / 6044
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 9 Nov 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 studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. Moreover, a baseline evaluation about sexual function and coping if often lacking.
Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:
- To assess sexual function, coping, emotional distress, and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy.
- To evaluate changes on the previous variables over 6 months.
The results obtained will be utilized for:
- planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis
- develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients.
Detailed description
Many recent reviews focused on QoL and the sexual function of patients with cervical cancer and have only evaluated the sexual dysfunctions of patients undergoing chemo-radiotherapy plus interventional radiotherapy.
The studies currently available in the literature are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. In fact, psychological factors caused by the cancer diagnosismay also negatively influence sexual functioning independently of the type of treatment or stage of cancer.
Common psychological issues included poor body image, decreased sense of femininity, anxiety about sexual interactions, and pain.
Consequently, related social issues may emerge, for example, the ability to maintain a sexual relationship, communication difficulties, and adverse effects on intimate relationships.
Women with cervical cancer have thus independently significant issues related to sexual functioning as a result of their disease and/or its treatment. The most important classification for cervical cancer is FIGO (International Federation Gynecology and Obstetrics) updated in 2021. Treatments for cervical cancer are different depending on this classification. Although early-stage cervical cancers have different prognosis and treatments with respect to invasive cervical cancers (surgery vs chemoradiation plus interventional radiotherapy), both types can have a major impact on patients' sexual function and coping, also dyadic coping since diagnosis.
For this reason, we decided to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:
Primary objectives: to assess sexual function and coping Secondary objective: to evaluate emotional distress; dyadic coping; anxiety and depression; QoL of patients with cervical cancer; association between coping and possible dissociative symptoms; changes on the previous variables over 6 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio-chemotherapy | – | Behavioral: psychological assessment evaluationCervical cancer patients undergoing radio-chemotherapy. |
| Surgery | – | Behavioral: psychological assessment evaluationCervical cancer patients undergoing surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical cancer neo diagnosis, pertaining to the Gynecologic Oncology and Radiotherapy Oncology Units of Fondazione Policlinico Universitario A. Gemelli IRCCS, candidates for surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines. Based on the evidence in literature and the historical of our Institution (throughout the year 2022: 81 radiotherapy plus chemotherapy, 64 surgery), assuming a slightly lower mean difference in psychological tests scores between the two groups due to the recent improvement in irradiation techniques since the previous publication, we calculated the final sample size is 154 patients, 88 undergoing radiotherapy plus chemotherapy and 66 undergoing surgery.
Key inclusion criteria (3 listed)
- Patients' age ≥ 18 years
- Patients undergoing non-conservative surgery or radiotherapy plus chemotherapy
- Patients able to understand and sign informed consent
Key exclusion criteria (5 listed)
- Patients' age > 65 years
- Patients with inability to express informed consent
- Patients denying informed consent
- Patients with psychopathological disturbances preexisting to the cancer diagnosis
- Patients affected by severe language deficits
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 |
|---|---|---|
| psychological assessment evaluationA prospective data collection will be performed with self-administered psychological measures, with the aim to compare two different groups of patients with cervical cancer neo diagnosis, candidates for non conservative surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines. Test will be repeated at Time 0 (firs access in radiotherapy Day Hospital, or first access in hospital ward for surgery), and Time 1 (after 6 months). | Behavioural | Radio-chemotherapy, Surgery |
Primary outcome
Assess sexual function in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Primary outcome is to assess sexual function of cervical cancer patients undergoing surgery vs patients undergoing radiotherapy plus chemotherapy. This dimension will be assessed by "Female Sexual Function Index" (FSFI), a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The index only measures sexual function in these domains over the previous 30 days. The FSFI can be used as a screening tool and as a potential diagnostic aid. A total cut-off score ≤ 26.55 has been proposed for the diagnosis of female sexual dysfunction, so any woman scoring below 26.55 should be considered at risk for sexual dysfunction.
Assess individual coping strategies in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Assessment of individual coping strategies will be done in both groups by The Mini-Mental Adjustment to Cancer (Mini-MAC), a 29-item instrument that evaluates cognitive and behavioral responses to cancer. The factors of the Mini-MAC are: Fighting Spirit, Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Each item is rated on a 4-point scale that ranges from "definitely does not apply to me" to "definitely applies to me". Each statement is rated on a scale from 1 (definitely not) to 4 (definitely yes), and the available scores for each of the four coping strategies range from 7 to 28 points. The higher the score, the greater the coping/behavior style in the patient's fight against cancer.
5 secondary outcomes
Evaluate dyadic coping in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate emotional Distress in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate Anxiety and Depression in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate the presence of any dissociative symtoms in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Evaluate quality of life dimensions in cervical cancer patients
Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, Italy
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 Uterine Cervical Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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 23 Feb 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess sexual function in cervical cancer patients (time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.). 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?
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 23 Feb 2024.